TracStar™ Large Distal Platform

FDA UDI

Class II (US FDA UDI)

by Imperative Care Inc.

Identity

Trade Name: TracStar™ Large Distal Platform FDA UDI
Generic Name: Vascular microcatheter FDA UDI
Device Name: TracStar™ LDP, 105 cm FDA UDI
Model / Reference: ICAC088105 FDA UDI
Description: TracStar™ LDP, 105 cm FDA UDI

Identifiers

Catalog Number: ICAC088105 FDA UDI
Primary DI / UDI-DI: 00812212030467 FDA UDI
510(k) Number: K212224 FDA UDI
FDA Product Code: DQY FDA UDI
QJP FDA UDI
GMDN Term: Vascular microcatheter FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.1250 FDA UDI
Commercial Distribution: Not 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

Yes

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

FDA UDI

Dimensions & Sizes

Size: Lumen/Inner Diameter — 0.088 Inch FDA UDI
Outer Diameter — 0.110 Inch FDA UDI
Catheter Length — 105 Centimeter FDA UDI

TracStar™ Large Distal Platform by Imperative Care Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K212224 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: Imperative Care Inc.

Sources (1)

FDA UDI f7094ccc-6ceb-426f-ada2-c997669aa8cd 39 fields · synced Jun 8, 2026