AccessGUDID - DEVICE: MegaVac Catheter (B251MCA1)

GUDID

Device Identifier (DI) Information

Brand Name: MegaVac Catheter
Version or Model: ATK
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MCA
Company Name: CAPTURE VASCULAR, INC.

Primary DI Number: B251MCA1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080210058 *Terms of Use

Device Description: The MegaVac Thrombectomy System is a single-use intravascular mechanical thrombectomy and aspiration system including a ThromboWire containing an embolectomy element. The MegaVac Catheter’s SafeSealTM technology utilizes a distal silicone coated nitinol braid that expands to temporarily occlude antegrade blood flow. The catheter body has inner and outer coaxial shafts that expand the braid, temporarily occluding the vessel and allowing for aspiration. The proximal handle assembly actuates the SafeSeal funnel. The ThromboWire consists of a nitinol embolectomy element that when expanded by the proximal actuation handle, can serve to pull matter towards the MegaVac catheter.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
58173	Thrombectomy suction catheter	A flexible or semi-flexible tube designed for the percutaneous, transluminal disruption and removal of clotted blood (i.e., a thrombus or thromboembolus) or other formed elements causing vascular obstruction in native/stented blood vessels, native/synthetic bypass grafts, and/or haemodialysis access grafts, through suction (aspiration) in conjunction with a syringe or dedicated suction pump system (pump not included). It may additionally be intended for infusion of fluids and/or used as a guide-catheter to facilitate introduction of a thrombectomy wire-net (not included) to remove residual thrombus. Collection containers may be included with the catheter. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DXE	Catheter, Embolectomy

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K040010	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 89e99bd6-dc7d-4f65-bc97-2b4c75747a97
Public Version Date: November 09, 2022
Public Version Number: 5
DI Record Publish Date: April 07, 2017