The following data is part of a premarket notification filed by Arrow Intl., Inc. with the FDA for Sheath Adapter, Model Sa-09847.
| Device ID | K021723 |
| 510k Number | K021723 |
| Device Name: | SHEATH ADAPTER, MODEL SA-09847 |
| Classification | Introducer, Catheter |
| Applicant | ARROW INTL., INC. 2400 BERNVILLE RD. Reading, PA 19605 |
| Contact | Brandon Epting |
| Correspondent | Brandon Epting ARROW INTL., INC. 2400 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 | 2002-05-24 |
| Decision Date | 2002-08-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30801902101571 | K021723 | 000 |
| 30801902026140 | K021723 | 000 |