Skip to content

Edwards Crimper 9600CR

by Edwards Lifesciences LLC 2 variants

Active United States. Also listed in GUDID (US).

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None ongoing

3 closed

Documents

PMA P140031

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 9 Nov 2026. What this means

Regulatory status

as of registry sync 9 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00690103198331 UDI-DI Date11 Dec 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA PMAAPPR from GUDID Approved NumberP140031 Date17 Jun 2015DecidedStatusActive

Official records

Recalls

3 recalls · FDA

    • Terminated Z-0835-2019 FDA Class II initiated 22 Jan 2019

    This action has been initiated to address complaint reports received for crimp balloon and inflation balloon component separation during TAVR procedures.

    • Terminated Z-2435-2018 FDA Class II initiated 11 Jun 2018

    SAPIEN 3 THV was packaged with the incorrect valve size with respect to the label.

    • Terminated Z-0293-2018 FDA Class I initiated 21 Jul 2017

    A component in the Certitude Loader may have a molding overflow defect that could detach during advancement of the delivery system and potentially embolize from the loader into the patient.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA PMA Active

Specification

GUDID

Trade name
Edwards Crimper
Generic name
Basic crimper
Model / Ref / Catalog
9600CR, 9600CRA
Primary DI / UDI-DI
00690103198331
PMA number
FDA product code
NPT, NPU
GMDN term
Basic crimper
Device class
Class III
GUDID distribution status
In Commercial Distribution

Related devices

Category: Vascular catheter introduction set, nonimplantableAortic transcatheter heart valve bioprosthesis, stent-like frameworkMitral transcatheter heart valve bioprosthesisBasic crimper

Cleared under the same submission (P140031)

Show all (12)

Other devices from Edwards Lifesciences LLC

See all devices from Edwards Lifesciences LLC →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date

Other properties (10)

  • Sterilise before use: No
  • 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