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The Shockwave C2+ Coronary IVL Catheter is a proprietary lithotripsy device delivered through the coronary arterial system of the heart to the site of an otherwise difficult to treat calcified stenosis, including calcified stenoses that are anticipated to exhibit resistance to full balloon dilatation or subsequent uniform coronary stent expansion. The IVL Catheter contains integrated lithotripsy emitters for the localized delivery of acoustic pressure pulse therapy. The lithotripsy technology generates acoustic pressure pulses within the target treatment site, disrupting calcium within the lesion allowing subsequent dilatation of a coronary artery stenosis using low balloon pressure. The system consists of the IVL Catheter, IVL Connector Cable and IVL Generator. The Shockwave C2+ Coronary IVL Catheter is available in four (4) sizes: 2.5x12 mm, 3.0x12 mm, 3.5x12 mm, and 4.0x12 mm. The Shockwave C2+ is compatible with a 5F guiding catheter and extensions, has a working length of 138 cm, and shaft depth markers at the proximal end. The catheter is coated with hydrophilic coating to 22.75 cm from the distal tip to reduce friction during device delivery.
Shockwave Medical, Inc.
3.0x12mm
In Commercial Distribution
- 00195451000010 ()
- Balloon Length: 12 Centimeter
- Balloon Diameter: 3.0 Millimeter
- Balloon Proximal Outer Diameter (OD): 0.045 Inch
- Length: 138 Centimeter
- Guidewire Compatibility: 5 French
C2PIVL3012
- Intravascular lithotripsy system balloon catheter, coronary
The Shockwave C2+ Coronary IVL Catheter is a proprietary lithotripsy device delivered through the coronary arterial system of the heart to the site of an otherwise difficult to treat calcified stenosis, including calcified stenoses that are anticipated to exhibit resistance to full balloon dilatation or subsequent uniform coronary stent expansion. The IVL Catheter contains integrated lithotripsy emitters for the localized delivery of acoustic pressure pulse therapy. The lithotripsy technology generates acoustic pressure pulses within the target treatment site, disrupting calcium within the lesion allowing subsequent dilatation of a coronary artery stenosis using low balloon pressure. The system consists of the IVL Catheter, IVL Connector Cable and IVL Generator. The Shockwave C2+ Coronary IVL Catheter is available in four (4) sizes: 2.5x12 mm, 3.0x12 mm, 3.5x12 mm, and 4.0x12 mm. The Shockwave C2+ is compatible with a 5F guiding catheter and extensions, has a working length of 138 cm, and shaft depth markers at the proximal end. The catheter is coated with hydrophilic coating to 22.75 cm from the distal tip to reduce friction during device delivery.
Shockwave Medical, Inc.
2.5x12mm
In Commercial Distribution
- 00195451000003 ()
- Balloon Length: 12 Millimeter
- Balloon Diameter: 2.5 Millimeter
- Balloon Proximal Outer Diameter (OD): 0.044 Inch
- Length: 138 Centimeter
- Guidewire Compatibility: 5 French
C2PIVL2512
- Intravascular lithotripsy system balloon catheter, coronary
RhodoLED® XL is a red light emitting LED lamp which is used exclusively in combination with Ameluz® (aminolevulinic acid hydrochloride) gel, 10% for lesion-directed and field-directed treatment of actinic keratoses (AKs) of mild-to-moderate severity on the face and scalp.
Biofrontera Pharma GmbH
US
In Commercial Distribution
- 04260308240164 ()
- Skin photodynamic therapy lamp
BF-RhodoLED® is a red light emitting LED lamp which is used exclusively in combination with Ameluz® (aminolevulinic acid hydrochloride) gel, 10% for lesion-directed and field-directed treatment of actinic keratoses (AKs) of mild-to-moderate severity on the face and scalp.
Biofrontera Pharma GmbH
US
In Commercial Distribution
- 04260308240102 ()
- Skin photodynamic therapy lamp
Shipping box carton containing 4 boxes of 10 individual devices; Not commercialized
Stockert GmbH
20624
In Commercial Distribution
- 04260166374360 ()
M004GEN100206241
- Cardiac ablation system irrigation tubing set
No Description
Stockert GmbH
20625
In Commercial Distribution
- 04260166374353 ()
M004GEN100206251
- Cardiac ablation system irrigation tubing set
Only commercialized as part of the 10 PK
Stockert GmbH
20626
In Commercial Distribution
- 04260166374346 ()
M004GEN100206260
- Cardiac ablation system irrigation tubing set
No Description
Biosense Webster Inc
SAT001
In Commercial Distribution
- 10846835009743 ()
SAT001
- Cardiac ablation system irrigation tubing set
No Description
BIOTRONIK SE & Co. KG
S DX 65/17
In Commercial Distribution
- 04035479158798 ()
- Distance tip-atrial dipole: 170 mm
- Length: 65 cm
436910
- Endocardial defibrillation lead
No Description
BIOTRONIK SE & Co. KG
S DX 65/15
In Commercial Distribution
- 04035479158781 ()
- Distance tip-atrial dipole: 150 mm
- Length: 65 cm
436909
- Endocardial defibrillation lead