Pounce ™ Thrombectomy

FDA UDI

Class II (US FDA UDI)

by Surmodics, Inc.

Identity

Trade Name: Pounce ™ Thrombectomy FDA UDI
Generic Name: Thrombectomy suction catheter FDA UDI
Device Name: Pounce Arterial Thrombectomy System with Handle FDA UDI
Model / Reference: PTS-0607-7F135 FDA UDI
Description: Pounce Arterial Thrombectomy System with Handle FDA UDI

Identifiers

Primary DI / UDI-DI: 00812339030326 FDA UDI
510(k) Number: K220501 FDA UDI
FDA Product Code: QEW FDA UDI
GMDN Term: Thrombectomy suction catheter FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.5150 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

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: Guidewire Compatibility — 7 French FDA UDI
Catheter Length — 135 Centimeter FDA UDI

Category: Thrombectomy suction catheter

Pounce ™ Thrombectomy by Surmodics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K220501 also covers:

Pounce ™ Thrombectomy — Surmodics, Inc.

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: Surmodics, Inc.

Sources (1)

FDA UDI 85ec1d94-f784-4e59-8f6c-8619f6c1403a 35 fields · synced May 30, 2026