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Penumbra Coil 400

FDA UDI

Class II (US FDA UDI)

by Penumbra, Inc.

Identity

Trade Name
Penumbra Coil 400 FDA UDI
Generic Name
Neurovascular embolization coil FDA UDI
Device Name
Coil 400 Standard, 15mm x 45cm FDA UDI
Model / Reference
4002C1545-A FDA UDI
Description
Coil 400 Standard, 15mm x 45cm FDA UDI

Identifiers

Catalog Number
4002C1545 FDA UDI
Primary DI / UDI-DI
00815948025103 FDA UDI
510(k) Number
K173614 FDA UDI
FDA Product Code
KRD FDA UDI
HCG FDA UDI
GMDN Term
Neurovascular embolization coil FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.3300 FDA UDI
882.5950 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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
MRI Safety
MR Conditional FDA UDI

Category: Neurovascular embolization coilSurgical microscope video camera, sterilizable

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

Similar devices

Also classified as Surgical microscope video camera, sterilizable.

Cleared under the same submission

K173614 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 5c634d13-2676-4fb9-9f70-0944dd394f71 35 fields · synced May 30, 2026