Chocolate XD PTCA Balloon Catheter NHC

FDA UDI

Class II (US FDA UDI)

by Trireme Medical, Llc

Identity

Trade Name: Chocolate XD PTCA Balloon Catheter NHC FDA UDI
Generic Name: Coronary angioplasty balloon catheter, basic FDA UDI
Device Name: Chocolate XD PTCA Balloon Catheter NHC FDA UDI
Model / Reference: A FDA UDI
Description: Chocolate XD PTCA Balloon Catheter NHC FDA UDI

Identifiers

Catalog Number: CD141403010RX FDA UDI
Primary DI / UDI-DI: M874CD141403010RX1 FDA UDI
510(k) Number: K153682 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

Chocolate XD PTCA Balloon Catheter NHC by Trireme Medical, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K153682 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: Trireme Medical, Llc

Sources (1)

FDA UDI f901b77e-1ada-4e74-bc13-003520621dde 35 fields · synced May 31, 2026