Skip to content

Affinity™ CP CBAP40

by Medtronic, Inc. 5 variants

Listed FDA GUDID listing, not in commercial distribution

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 Number20643169433247 UDI-DI Date30 Oct 2016ListedStatusListed GUDID: not 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  • Withdrawn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
Affinity™ CP
Generic Name
Cardiopulmonary bypass system centrifugal pump
Model / Reference
CBAP40
Primary DI / UDI-DI
20643169433247
510(k) Number
FDA Product Code
KFM
GMDN Term
Cardiopulmonary bypass system centrifugal pump
Device Class
Class II
Regulation Number
870.4360
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K132712)

Show all (10)

Other devices from Medtronic, Inc.

See all devices from Medtronic, Inc. →

Properties

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

Other properties (10)

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