The following data is part of a premarket notification filed by Access Scientific, Llc with the FDA for The Arterial Wand Safety Introducer With Arterial Catheter Made Of Chronoflex C With Bioguard Technology.
| Device ID | K181563 |
| 510k Number | K181563 |
| Device Name: | The ARTERIAL WAND Safety Introducer With Arterial Catheter Made Of ChronoFlex C With BioGUARD Technology |
| Classification | Catheter, Percutaneous |
| Applicant | Access Scientific, LLC 3910 Sorrento Valley Boulevard, Suite 200 San Diego, CA 92121 |
| Contact | Martina Nguyen |
| Correspondent | Martina Nguyen Access Scientific, LLC 3910 Sorrento Valley Boulevard, Suite 200 San Diego, CA 92121 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-14 |
| Decision Date | 2018-09-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20859821006692 | K181563 | 000 |