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PhotoFix Decellularized Bovine Pericardium PFP6X8

by Artivion, Inc. 2 variants

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00877234001635 UDI-DI Date29 May 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
PhotoFix Decellularized Bovine Pericardium
Generic Name
Cardiovascular patch, animal-derived
Model / Ref / Catalog
PFP6X8
Primary DI / UDI-DI
00877234001635
510(k) Number
FDA Product Code
PSQ
GMDN Term
Cardiovascular patch, animal-derived
Device Class
Class II
Regulation Number
870.3470
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Safe
Size
Length — 8 Centimeter
Width — 6 Centimeter

Related devices

Cleared under the same submission (K162506)

Cleared under the same submission (K172085)

Cleared under the same submission (K183635)

Cleared under the same submission (K993288)

Other devices from Artivion, Inc.

See all devices from Artivion, Inc. →

Properties

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

Other properties (7)

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