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Cardioxyl ® 73I30A

by Peters Surgical

Ref 73I30A

Cardioxyl ® 73I30A is a device classified as Class III in the EU and Class II in the US made by Peters Surgical, registered in EUDAMED on 6 Nov 2026 (Basic UDI-DI B-03661522037874), cleared under FDA 510(k) K060163 on 11 Oct 2006 and listed in FDA GUDID since 9 Jan 2020 (UDI-DI 03661522037874), active as of 7 Nov 2026. 2 FDA recalls are linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE MDR CE MDD 510(k)

Valid until

6 Apr 2030

CE MDR certificate

FDA recalls

None ongoing

2 closed

Documents

1 certificate

Certifier GMED SAS

510(k) K060163

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberB-03661522037874 Basic UDI-DI 03661522037874UDI-DIDate6 Nov 2026RegisteredStatusActive
European UnionCE/MDD EUDAMED NumberB-03661522037874 Basic UDI-DI 03661522037874UDI-DIDate6 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03661522037874 UDI-DI Date9 Jan 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK060163 Date11 Oct 2006DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-03661522037874 registered 6 Nov 2026 Active· +1 more in the status table
  • FDA 510(k) K060163 decided 11 Oct 2006 Active
  • FDA GUDID UDI-DI 03661522037874 listed 9 Jan 2020 Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 40252 Active Amended

    Technical documentation EU MDR

    Certifier
    GMED SAS 0459
    Issued
    7 Aug 2026
    Expires
    6 Apr 2030
    Reason
    Other

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-2676-2014 FDA Class II initiated 25 Jun 2014
    • Terminated Z-2675-2014 FDA Class II initiated 25 Jun 2014

    A potential splitting of the surface treatment of the thread ends on certain sutures has recently been identified.

Timeline

5 dated events

  1. Cleared FDA 510(k) K060163
  2. Recall initiated FDA recalls Z-2676-2014
  3. Recall initiated FDA recalls Z-2675-2014
  4. Listed FDA GUDID 03661522037874
  5. Registered EUDAMED B-03661522037874

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR, CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Cardioxyl® EUDAMED
Cardioxyl ® GUDID
Generic name
Polyester suture, non-bioabsorbable, multifilament, non-antimicrobial
Device name
Cardioxyl
Model / reference
73I30A
Primary DI / UDI-DI
03661522037874
Basic UDI-DI
B-03661522037874, 3661522DTSU1201VW
510(k) Number
FDA product code
GAT
EMDN code
H010201020201, H010201020202
GMDN term
Polyester suture, non-bioabsorbable, multifilament, non-antimicrobial
Device class
Class III EUDAMED
Class II GUDID
Regulation number
878.5000
EU registration type
Legacy device (under a directive)
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class III
GUDID
Class II

Device class is stated on each registry's own scale: Class III in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Polyester suture, non-bioabsorbable, multifilament

Cleared under the same submission (K060163)

and 8 more cleared under K060163

Similar devices in this category

Other devices filed under POLYESTER MULTIFILAMENT WITH NEEDLE FOR OPEN SURGERY.

Other devices from Peters Surgical

See all devices from Peters Surgical →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Contains animal tissues or cells
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)