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RenovoCath 009003 rev 4

by RenovoRx

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00851994005003 UDI-DI Date19 Nov 2020ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
RenovoCath
Generic Name
Intravascular occluding balloon catheter, image-guided
Model / Ref / Catalog
009003 rev 4, MMRC120-DB-1111
Primary DI / UDI-DI
00851994005003
510(k) Number
FDA Product Code
MJN
GMDN Term
Intravascular occluding balloon catheter, image-guided
Device Class
Class II
Regulation Number
870.4450
GUDID distribution status
In Commercial Distribution
Size
Guidewire Diameter — 0.014 Inch
Introducer Sheath Compatibility — 6 French
Catheter Working Length — 86 Centimeter
Outer Diameter — 0.076 Inch

Related devices

Category: Peripheral vascular intervention infusion catheterIntravascular occluding balloon catheter, image-guided

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (9)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No