The following data is part of a premarket notification filed by Access Scientific, Llc with the FDA for The Powerwand Safety Introducer With An Extended Dwell Catheter.
| Device ID | K131300 |
| 510k Number | K131300 |
| Device Name: | THE POWERWAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER |
| Classification | Introducer, Catheter |
| Applicant | ACCESS SCIENTIFIC, LLC 3910 Sorrento Valley Blvd Ste 200 San Diego, CA 92121 |
| Contact | Albert Misajon |
| Correspondent | Albert Misajon ACCESS SCIENTIFIC, LLC 3910 Sorrento Valley Blvd Ste 200 San Diego, CA 92121 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-07 |
| Decision Date | 2013-06-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00859821006681 | K131300 | 000 |
| 30859821006026 | K131300 | 000 |
| 30859821006033 | K131300 | 000 |
| 30859821006040 | K131300 | 000 |
| 30859821006057 | K131300 | 000 |
| 20859821006067 | K131300 | 000 |
| 30859821006071 | K131300 | 000 |
| 30859821006088 | K131300 | 000 |
| 30859821006514 | K131300 | 000 |
| 30859821006538 | K131300 | 000 |
| 30859821006019 | K131300 | 000 |