Isaac

FDA UDI

Class II (US FDA UDI)

by Microvention Inc.

Identity

Trade Name: ISAAC FDA UDI
Generic Name: Vascular guide-catheter, single-use FDA UDI
Device Name: ISAAC Catheter - SIM2 FDA UDI
Model / Reference: INN6150SIM2-3D FDA UDI
Description: ISAAC Catheter - SIM2 FDA UDI

Identifiers

Catalog Number: INN6150SIM2-3D FDA UDI
Primary DI / UDI-DI: 00842429113608 FDA UDI
510(k) Number: K222115 FDA UDI
FDA Product Code: DQY FDA UDI
QJP FDA UDI
GMDN Term: Vascular guide-catheter, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.1250 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

Yes

FDA UDI

Category: Vascular guide-catheter, single-use

Isaac by Microvention Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Vascular guide-catheter, single-use.

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Surefire Guiding Catheter — Surefire Medical, Inc. · Class II
SHERPA NX BALANCED™ — MEDTRONIC, INC. · Class II
Zebra — QApel Medical, Inc. · Class II
Mach1™ — Boston Scientific · Class II
SHERPA NX BALANCED — MEDTRONIC, INC. · Class II

Cleared under the same submission

K222115 also covers:

ISAAC — MICROVENTION INC.
ISAAC — MICROVENTION 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: Microvention Inc.

Sources (1)

FDA UDI 07a15c53-7faa-45ec-960f-6a7812e49402 37 fields · synced May 31, 2026