The following data is part of a premarket notification filed by Access Scientific, Llc with the FDA for The Cvc Wand Safety Introducer With Valved Peelable Sheath.
| Device ID | K131148 |
| 510k Number | K131148 |
| Device Name: | THE CVC WAND SAFETY INTRODUCER WITH VALVED PEELABLE SHEATH |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-23 |
| Decision Date | 2013-09-04 |
| Summary: | summary |