| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 00850007221027 [Primary] |
| DYB | Introducer, Catheter |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-07-26 |
| Device Publish Date | 2023-07-18 |
| 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 |