Apollo Balloon Dilatation Catheter rev 02

by BrosMed Medical Co., Ltd. 55 variants

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

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

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number06958481454130 UDI-DI	Date26 Sep 2016Listed	StatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: Apollo Balloon Dilatation Catheter
Generic Name: Coronary angioplasty balloon catheter, basic
Model / Ref / Catalog: rev 02, 802-2522U

Primary DI / UDI-DI: 06958481454130
510(k) Number: K153742
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
Lot / Batch Number
Expiration Date

Other properties (10)

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
Manufacturing Date: No