The following data is part of a premarket notification filed by Xentek Medical, Inc. with the FDA for Tearaway Introducer Sheath.
| Device ID | K000313 |
| 510k Number | K000313 |
| Device Name: | TEARAWAY INTRODUCER SHEATH |
| Classification | Introducer, Catheter |
| Applicant | XENTEK MEDICAL, INC. 6136 FM 1616 Athens, TX 75751 |
| Contact | Jim Eddings |
| Correspondent | Jim Eddings XENTEK MEDICAL, INC. 6136 FM 1616 Athens, TX 75751 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-01 |
| Decision Date | 2000-06-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 40889942615446 | K000313 | 000 |
| 10884389857977 | K000313 | 000 |