NC Quantum Apex™ H7493912420500

by Boston Scientific

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number08714729783541 UDI-DI	Date24 Sep 2016Listed	StatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: NC Quantum Apex™
Generic Name: Coronary angioplasty balloon catheter, basic
Model / Reference: H7493912420500

Primary DI / UDI-DI: 08714729783541
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

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Properties

Sterile
Single Use
Prescription Use
Lot / Batch Number
Expiration Date

Other properties (9)

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