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Sapphire NC 24 Coronary Dilatation Catheter 494001812

by OrbusNeich Medical (ShenZhen) Co., Ltd.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06934955905834 UDI-DI Date17 Feb 2022ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Sapphire NC 24 Coronary Dilatation Catheter
Generic Name
Coronary angioplasty balloon catheter, basic
Model / Reference
494001812
Primary DI / UDI-DI
06934955905834
510(k) Number
FDA Product Code
LOX
GMDN Term
Coronary angioplasty balloon catheter, basic
Device Class
Class II
Regulation Number
870.5100
GUDID distribution status
In Commercial Distribution

Related devices

Category: Coronary angioplasty balloon catheter, basic

Cleared under the same submission (K211807)

Show all (12)

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Properties

  • Sterile
  • Single Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (9)

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