The following data is part of a premarket notification filed by Arrow Intl., Inc. with the FDA for Arrow Transseptal Super Arrow-flex Percutaneous Set.
| Device ID | K970229 |
| 510k Number | K970229 |
| Device Name: | ARROW TRANSSEPTAL SUPER ARROW-FLEX PERCUTANEOUS SET |
| Classification | Introducer, Catheter |
| Applicant | ARROW INTL., INC. 3000 BERNVILLE RD. Reading, PA 19605 |
| Contact | Thomas D Nickel |
| Correspondent | Thomas D Nickel ARROW INTL., INC. 3000 BERNVILLE RD. Reading, PA 19605 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-21 |
| Decision Date | 1998-02-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30801902098086 | K970229 | 000 |
| 30801902009334 | K970229 | 000 |
| 30801902001260 | K970229 | 000 |
| 30801902001253 | K970229 | 000 |
| 40801902122528 | K970229 | 000 |