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 | K182243 |
| 510k Number | K182243 |
| Device Name: | The CVC WAND Safety Introducer With Valved Peelable Sheath |
| Classification | Introducer, Catheter |
| 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 | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-20 |
| Decision Date | 2018-09-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20859821006715 | K182243 | 000 |
| 20859821006708 | K182243 | 000 |