Sapphire ULTRA Coronary Dilatation Catheter

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref 7920-012-11

by OrbusNeich Medical (ShenZhen) Co., Ltd.

Identity

Trade Name: Sapphire ULTRA EUDAMED
Sapphire ULTRA Coronary Dilatation Catheter FDA UDI
Generic Name: Coronary angioplasty balloon catheter, basic FDA UDI
Device Name: Sapphire ULTRA Coronary Dilatation Catheter EUDAMED
Model / Reference: 7920-012-11 EUDAMEDFDA UDI

Identifiers

Primary DI / UDI-DI: 06934955979170 EUDAMEDFDA UDI
Basic UDI-DI: 693495597912B EUDAMED
Direct Marketing DI: 06934955979170 EUDAMED
510(k) Number: K233505 FDA UDI
FDA Product Code: LOX FDA UDI
EMDN Code: C010401020101 PTCA BALLOON DILATION CATHETERS EUDAMED
GMDN Term: Coronary angioplasty balloon catheter, basic FDA UDI

Classification

Device Class: Class III EUDAMED
Class II FDA UDI
Regulation Number: 870.5100 FDA UDI
Market of Registration: Belgium EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

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

Similar devices

Also classified as Coronary angioplasty balloon catheter, basic.

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SPRINTER® LEGEND — MEDTRONIC, INC. · Class II
SPRINTER LEGEND — MEDTRONIC, INC. · Class II
Emerge™ — Boston Scientific · Class II

Cleared under the same submission

K233505 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class II	Unknown
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 (2)

FDA UDI 5685c928-1b22-4c46-9004-0e2e4b26c135 33 fields · synced Oct 8, 2026
EUDAMED ad6fbb4e-06fe-4638-848f-c34d82202e66 61 fields · synced Oct 8, 2026