← Back to catalogue

Peregrine System™ Infusion Catheter

FDA UDI

Class II (US FDA UDI)

by Ablative Solutions, Inc.

Identity

Trade Name
Peregrine System™ Infusion Catheter FDA UDI
Generic Name
Peripheral vascular intervention infusion catheter FDA UDI
Device Name
Peregrine System™ Infusion Catheter (3-4 mm), 510k, US FDA UDI
Model / Reference
FG32112 FDA UDI
Description
Peregrine System™ Infusion Catheter (3-4 mm), 510k, US FDA UDI

Identifiers

Primary DI / UDI-DI
00862468000356 FDA UDI
510(k) Number
K231279 FDA UDI
FDA Product Code
KRA FDA UDI
GMDN Term
Peripheral vascular intervention infusion catheter 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

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

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

Dimensions & Sizes

Size
Length — 86 Centimeter FDA UDI
Outer Diameter — 0.077 Inch FDA UDI

Category: Peripheral vascular intervention infusion catheter

Peregrine System™ Infusion Catheter by Ablative Solutions, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Peripheral vascular intervention infusion catheter.

Cleared under the same submission

K231279 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Ablative Solutions, Inc.

Sources (1)

  • FDA UDI 7b2ea29b-209f-441a-ad50-d62cb5b5fd76 36 fields · synced May 30, 2026