Avance Steerable Catheter AVA85-115-50

GUDID 00850007221027

Cardiovascular catheter introducer

Biocardia, Inc.

Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use

• Primary Device ID: 00850007221027
• NIH Device Record Key: 66a3eafc-bbbc-4061-883d-4438f81b6c9d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Avance Steerable Catheter
• Version Model Number: AVA85-115-50
• Catalog Number: AVA85-115-50
• Company DUNS: 877688069
• Company Name: Biocardia, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850007221027 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190941

FDA Product Code

• DYB: Introducer, Catheter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-26
• Device Publish Date: 2023-07-18

Devices Manufactured by Biocardia, Inc.

• 00850007221003 - Avance Steerable Introducer: 2023-07-26 Cardiovascular catheter introducer
• 00850007221010 - Avance Steerable Introducer: 2023-07-26 Cardiovascular Catheter introducer
• 00850007221027 - Avance Steerable Catheter: 2023-07-26Cardiovascular catheter introducer
• 00850007221027 - Avance Steerable Catheter: 2023-07-26 Cardiovascular catheter introducer
• 00866749000271 - Helical Infusion Catheter: 2023-07-25 Catheter, percutaneous
• 00866749000295 - Morph DNA: 2023-07-25 Guide Catheter
• 00866749000202 - Morph Universal Deflectable Guide Catheter: 2019-01-23
• 00866749000240 - Morph AccessPro Steerable Introducer: 2019-01-23
• 00866749000257 - Morph AccessPro Steerable Introducer: 2019-01-23