DEVICE: Secondi™ Support Catheter (M781S1835201501)

Device Identifier (DI) Information

Secondi™ Support Catheter
S18/35-20-150
In Commercial Distribution

Thermopeutix, Inc.
M781S1835201501
HIBCC

1
138648154 *Terms of Use
The Secondi™ Support Catheter is a dual lumen catheter with an integrated spine wire and two guidewire lumens designed for use in the peripheral vasculature. The catheter provides support for guidewires during interventional procedures and allows for the exchange of one proximally located guidewire for another while maintaining access to the distal vasculature over a second distal guidewire. The Secondi™ Support Catheter has a hydrophilic coating on the distal portion of the catheter, and is compatible with various guidewire diameters and lengths. The catheter has a single radiopaque marker band located at the distal tip of each of the catheter’s guide wire lumens.
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
32151 Peripheral vascular intervention infusion catheter
A flexible tube designed primarily to enable the delivery of diagnostic or therapeutic solutions into the peripheral vasculature during a cardiovascular procedure (e.g., delivery of an antithrombotic agent); some types may in addition be applied to coronary or pulmonary vasculature. It is percutaneously introduced and may include features such as side holes for infusion across a specific region, an expanding frame to disrupt clotted blood to improve diffusion, or a balloon to support infusion at a specific region. It is neither a peripherally-inserted central venous catheter, dedicated occluding catheter, nor superselective small vessel microcatheter. This is a single-use device.
Active false
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
DQY Catheter, Percutaneous
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K130850 000
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Handling Environment Temperature: between -29 and 55 Degrees Celsius
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: Shaft Length: 150 cm
Device Size Text, specify: Tracking Length: 20 mm
Device Size Text, specify: Proximal Guide Wire Compatibility: 0.035”
Device Size Text, specify: Distal Guide Wire Compatibility: 0.018”
Device Size Text, specify: Sheath Compatibility: 8 Fr
CLOSE

Device Record Status

fb1e2f82-1441-460e-af5d-cdc56c074bb6
June 10, 2022
6
September 19, 2016
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
1-858-549-1760
customer.service@thermopeutix.com
CLOSE