The following data is part of a premarket notification filed by Vygon Corp. with the FDA for Vygon Split Cannula Introducer.
| Device ID | K010913 |
| 510k Number | K010913 |
| Device Name: | VYGON SPLIT CANNULA INTRODUCER |
| Classification | Introducer, Catheter |
| Applicant | VYGON CORP. 1129 BLOOMFIELD AVE. West Caldwell, NJ 07006 |
| Contact | Robert Schiff |
| Correspondent | Robert Schiff VYGON CORP. 1129 BLOOMFIELD AVE. West Caldwell, NJ 07006 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-03-27 |
| Decision Date | 2001-09-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30849884002363 | K010913 | 000 |
| 30849884002042 | K010913 | 000 |
| 30849884004268 | K010913 | 000 |