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Walrus

FDA UDI

Class II (US FDA UDI)

by Q’Apel Medical, Inc.

Identity

Trade Name
Walrus FDA UDI
Generic Name
Vascular guide-catheter, single-use FDA UDI
Device Name
087 Balloon Guide Catheter System, 90cm FDA UDI
Model / Reference
FG 00100-01 FDA UDI
Description
087 Balloon Guide Catheter System, 90cm FDA UDI

Identifiers

Catalog Number
BG8087-090 FDA UDI
Primary DI / UDI-DI
00857545008011 FDA UDI
510(k) Number
K192525 FDA UDI
FDA Product Code
DQY FDA UDI
MJN FDA UDI
GMDN Term
Vascular guide-catheter, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1250 FDA UDI
870.4450 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

No

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

No

FDA UDI

Category: Vascular guide-catheter, single-use

Walrus by Q’Apel Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Cleared under the same submission

K192525 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Q’Apel Medical, Inc.

Sources (1)

  • FDA UDI 27a15081-ec16-440c-a632-9f863dd4e138 35 fields · synced May 30, 2026