Prowler

FDA UDI

Class II (US FDA UDI)

by Medos International Sàrl

Identity

Trade Name: PROWLER FDA UDI
Generic Name: Vascular microcatheter FDA UDI
Device Name: PROWLER 14 Infusion Catheter with 2 Markers Infusion Catheter 2.3F (0.75 mm) 1.9F (0.65 mm) .0165 Inch (0.4 mm) 3cm 50 cm 150 cm Contents: 1 Infusion Catheter and 1 Shape Mandrel. Minimum Guiding Catheter I.D. / Dia. .035 Inch (0.9 mm) FDA UDI
Model / Reference: 606-151X FDA UDI
Description: PROWLER 14 Infusion Catheter with 2 Markers Infusion Catheter 2.3F (0.75 mm) 1.9F (0.65 mm) .0165 Inch (0.4 mm) 3cm 50 cm 150 cm Contents: 1 Infusion Catheter and 1 Shape Mandrel. Minimum Guiding Catheter I.D. / Dia. .035 Inch (0.9 mm) FDA UDI

Identifiers

Catalog Number: 606151X FDA UDI
Primary DI / UDI-DI: 10886704028628 FDA UDI
510(k) Number: K003925 FDA UDI
K972518 FDA UDI
K993266 FDA UDI
FDA Product Code: KRA FDA UDI
GMDN Term: Vascular microcatheter FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.1210 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

Category: Vascular microcatheter

Prowler by Medos International Sàrl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Vascular microcatheter.

Velocity Delivery Microcatheter — PENUMBRA, INC. · Class II
Knight Microcatheter — ZIEN Medical Technologies, LLC · Class II
Merit Pursue™ — Merit Medical Systems, Inc. · Class I
Renegade™ HI-FLO™ Kit — Boston Scientific · Class II
Merit Maestro® — Merit Medical Systems, Inc. · Class II
Lantern Delivery Catheter — PENUMBRA, INC. · Class II
Direxion™ Fathom™-16 System — Boston Scientific · Class II
Direxion™ — Boston Scientific · Class II

Cleared under the same submission

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: Medos International Sàrl

Sources (1)

FDA UDI 8bf3ea96-9d40-4cc8-be77-a5d6409ed097 37 fields · synced May 30, 2026