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Chocolate XD PTCA Balloon Catheter Hydrophilic Coated

FDA UDI

Class II (US FDA UDI)

by Trireme Medical, Llc

Identity

Trade Name
Chocolate XD PTCA Balloon Catheter Hydrophilic Coated FDA UDI
Generic Name
Coronary angioplasty balloon catheter, basic FDA UDI
Model / Reference
A FDA UDI

Identifiers

Primary DI / UDI-DI
M874CX141402520RX1 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

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Coronary angioplasty balloon catheter, basic

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

Similar devices

Also classified as Coronary angioplasty balloon catheter, basic.

Cleared under the same submission

K153682 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Trireme Medical, Llc

Sources (1)

  • FDA UDI 93d27524-0152-4c35-a0a7-3e52ae148625 33 fields · synced Jun 1, 2026