Sapphire NC ULTRA Coronary Dilatation Catheter

FDA UDI

Class II (US FDA UDI)

by OrbusNeich Medical (ShenZhen) Co., Ltd.

Identity

Trade Name: Sapphire NC ULTRA Coronary Dilatation Catheter FDA UDI
Generic Name: Coronary angioplasty balloon catheter, basic FDA UDI
Model / Reference: 8232-010-11 FDA UDI

Identifiers

Primary DI / UDI-DI: 06934955982323 FDA UDI
510(k) Number: K233499 FDA UDI
FDA Product Code: LOX FDA UDI
GMDN Term: Coronary angioplasty balloon catheter, basic FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.5100 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Coronary angioplasty balloon catheter, basic

Sapphire NC ULTRA Coronary Dilatation Catheter by OrbusNeich Medical (ShenZhen) Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID

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Also classified as Coronary angioplasty balloon catheter, basic.

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Cleared under the same submission

K233499 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: OrbusNeich Medical (ShenZhen) Co., Ltd.

Sources (1)

FDA UDI 1becf784-2a0d-4654-be54-176c22b53ef9 33 fields · synced May 31, 2026