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Comaneci Petit ANPP7188

by Rapid Medical Ltd

Comaneci Petit ANPP7188 is a Class II device made by Rapid Medical Ltd, granted FDA De Novo DEN170064 on 24 Apr 2019 and listed in FDA GUDID since 17 May 2019 (UDI-DI 07290015107143), active as of 12 Nov 2026.

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

De Novo

Valid until

No expiry

De Novo grant is not time-limited

FDA recalls

None found

in data synced 12 Nov 2026

Documents

De Novo DEN170064

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07290015107143 UDI-DI Date17 May 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA De NovoDENG from GUDID De Novo granted · Direct NumberDEN170064 Date24 Apr 2019DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA De Novo DEN170064 decided 24 Apr 2019 Active
  • FDA GUDID UDI-DI 07290015107143 listed 17 May 2019 Listed

Timeline

2 dated events

  1. Granted FDA De Novo DEN170064
  2. Listed FDA GUDID 07290015107143

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA De Novo Active

Specification

GUDID

Trade name
Comaneci Petit
Generic name
Bare-metal intracranial vascular stent
Model / reference
ANPP7188
Primary DI / UDI-DI
07290015107143
De Novo Number
FDA product code
PUU
GMDN term
Bare-metal intracranial vascular stent
Device class
Class II
Regulation number
882.5955
GUDID distribution status
In Commercial Distribution

Related devices

Category: Bare-metal intracranial vascular stent

Cleared under the same submission (DEN170064)

Other devices from Rapid Medical Ltd

See all devices from Rapid Medical Ltd →

Properties

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