Simon Nitinol Filter™

FDA UDI

Class II (US FDA UDI)

by Bard Peripheral Vascular

Identity

Trade Name: Simon Nitinol Filter™ FDA UDI
Generic Name: Vena cava filter, temporary/permanent FDA UDI
Device Name: Simon Nitinol Filter™ , Vena Cava Filter, Anticubital Introducer Set FDA UDI
Model / Reference: 3320A FDA UDI
Description: Simon Nitinol Filter™ , Vena Cava Filter, Anticubital Introducer Set FDA UDI

Identifiers

Catalog Number: 3320A FDA UDI
Primary DI / UDI-DI: 00801741109218 FDA UDI
510(k) Number: K970099 FDA UDI
FDA Product Code: DTK FDA UDI
GMDN Term: Vena cava filter, temporary/permanent FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.3375 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

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

FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Vena cava filter, temporary/permanent

Simon Nitinol Filter™ by Bard Peripheral Vascular — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Bard Peripheral Vascular

Sources (1)

FDA UDI d2a42e0d-f480-4c8c-8319-c24228feed8f 37 fields · synced Jun 6, 2026