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Perceval S ICV1235

by Corcym Inc.

Perceval S ICV1235 is a Class III device made by Corcym Inc., approved under FDA PMA P150011 on 8 Jan 2016 and listed in FDA GUDID since 6 Jun 2016 (UDI-DI 08022057014832), active as of 23 Oct 2026. One FDA recall is linked to it.

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

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None ongoing

1 closed

Documents

PMA P150011

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08022057014832 UDI-DI Date6 Jun 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA PMAAPPR from GUDID Approved NumberP150011 Date8 Jan 2016DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA PMA P150011 decided 8 Jan 2016 Active
  • FDA GUDID UDI-DI 08022057014832 listed 6 Jun 2016 Listed

Recalls

1 recall · FDA

    • Terminated Z-0716-2017 FDA Class II initiated 31 Oct 2016

    Sorin Group USA, Inc. announces a voluntary field action for the Perceval Sutureless Heart Valve due to updated steps associated with the implantation procedure.

Timeline

3 dated events

  1. Approved FDA PMA P150011
  2. Listed FDA GUDID 08022057014832
  3. Recall initiated FDA recalls Z-0716-2017

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA PMA Active

Specification

GUDID

Trade name
Perceval S
Generic name
Self-expandable heart valve bioprosthesis collapsing tool, single-use
Model / reference
ICV1235
Primary DI / UDI-DI
08022057014832
FDA product code
LWR
GMDN term
Self-expandable heart valve bioprosthesis collapsing tool, single-use
Device class
Class III
GUDID distribution status
In Commercial Distribution

Related devices

Category: Self-expandable heart valve bioprosthesis collapsing tool, single-use

Cleared under the same submission (P150011)

and 8 more cleared under P150011

Similar devices

Other devices filed under FDA product code LWR (heart-valve, non-allograft tissue).

Other devices from Corcym Inc.

  • TriMemo TRIM-26

    Class II

  • TriMemo TRIM-28

    Class II

  • TriMemo TRIM-30

    Class II

  • TriMemo TRIM-32

    Class II

See all devices from Corcym Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)