← Back to catalogue

Penumbra Coil 400

FDA UDI

Class II (US FDA UDI)

by Penumbra, Inc.

Identity

Trade Name
Penumbra Coil 400 FDA UDI
Generic Name
Embolization implant kit FDA UDI
Device Name
PC400 Cplx Std, 6x12 FDA UDI
Model / Reference
4002C0612 FDA UDI
Description
PC400 Cplx Std, 6x12 FDA UDI

Identifiers

Primary DI / UDI-DI
M4244002C06120 FDA UDI
510(k) Number
K103305 FDA UDI
FDA Product Code
HCG FDA UDI
GMDN Term
Embolization implant kit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.5950 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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Embolization implant kit

Penumbra Coil 400 by Penumbra, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Embolization implant kit.

Cleared under the same submission

K103305 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
Penumbra, Inc.

Sources (1)

  • FDA UDI a117291a-bc51-4b38-89b8-a84b39a34a4a 34 fields · synced Jun 8, 2026