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Midway

FDA UDI

Class II (US FDA UDI)

by Penumbra, Inc.

Identity

Trade Name
MIDWAY FDA UDI
Generic Name
Vascular guide-catheter, single-use FDA UDI
Device Name
MIDWAY 62 Delivery Catheter, 115cm, no CE FDA UDI
Model / Reference
62MWAY115-A FDA UDI
Description
MIDWAY 62 Delivery Catheter, 115cm, no CE FDA UDI

Identifiers

Primary DI / UDI-DI
00815948028197 FDA UDI
510(k) Number
K233201 FDA UDI
FDA Product Code
QJP FDA UDI
DQY 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

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

No

FDA UDI

Category: Vascular guide-catheter, single-use

Midway by Penumbra, 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

K233201 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Penumbra, Inc.

Sources (1)

  • FDA UDI 9b093ed8-31fc-4104-8e28-f3e6f958cb0f 34 fields · synced Jun 1, 2026