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Avance Steerable Catheter

FDA UDI

Class II (US FDA UDI)

by Biocardia, Inc.

Identity

Trade Name
Avance Steerable Catheter FDA UDI
Generic Name
Vascular guide-catheter, single-use FDA UDI
Device Name
Cardiovascular catheter introducer FDA UDI
Model / Reference
AVA85-115-50 FDA UDI
Description
Cardiovascular catheter introducer FDA UDI

Identifiers

Catalog Number
AVA85-115-50 FDA UDI
Primary DI / UDI-DI
00850007221027 FDA UDI
510(k) Number
K190941 FDA UDI
FDA Product Code
DYB FDA UDI
GMDN Term
Vascular guide-catheter, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1340 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
MRI Safety
MR Unsafe FDA UDI

Category: Vascular guide-catheter, single-use

Avance Steerable Catheter by Biocardia, 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

K190941 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Biocardia, Inc.

Sources (1)

  • FDA UDI 66a3eafc-bbbc-4061-883d-4438f81b6c9d 35 fields · synced Jun 6, 2026