The following data is part of a premarket notification filed by Bard Peripheral Vascular, Inc. with the FDA for Peripheral Vascular Sheath Tunneler Sterilization Cassette.
| Device ID | K042062 |
| 510k Number | K042062 |
| Device Name: | PERIPHERAL VASCULAR SHEATH TUNNELER STERILIZATION CASSETTE |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | BARD PERIPHERAL VASCULAR, INC. 1625 WEST 3RD ST. Tempe, AZ 85281 |
| Contact | Shari Allen |
| Correspondent | J.a. Van Vugt KEMA QUALITY B.V. 4377 COUNTY LINE ROAD Chalfont, PA 18914 |
| Product Code | KCT |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-08-02 |
| Decision Date | 2004-09-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00801741090516 | K042062 | 000 |
| 00801741090264 | K042062 | 000 |