The following data is part of a premarket notification filed by Xentek Medical, Inc. with the FDA for Coaxial Dilator Set.
| Device ID | K000737 |
| 510k Number | K000737 |
| Device Name: | COAXIAL DILATOR SET |
| Classification | Dilator, Vessel, For Percutaneous Catheterization |
| 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 | DRE |
| CFR Regulation Number | 870.1310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-07 |
| Decision Date | 2000-08-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04046964349270 | K000737 | 000 |
| 04046964348983 | K000737 | 000 |
| 04046964348969 | K000737 | 000 |
| 04046964348945 | K000737 | 000 |
| 04046964348921 | K000737 | 000 |
| 04046964348907 | K000737 | 000 |
| 04046964348884 | K000737 | 000 |
| 04046964348860 | K000737 | 000 |
| 04046964348846 | K000737 | 000 |
| 04046964327926 | K000737 | 000 |
| 20841268106974 | K000737 | 000 |
| 04046964349003 | K000737 | 000 |
| 04046964349027 | K000737 | 000 |
| 04046964349041 | K000737 | 000 |
| 04046964349249 | K000737 | 000 |
| 04046964349225 | K000737 | 000 |
| 04046964349201 | K000737 | 000 |
| 04046964349188 | K000737 | 000 |
| 04046964349164 | K000737 | 000 |
| 04046964349140 | K000737 | 000 |
| 04046964349126 | K000737 | 000 |
| 04046964349102 | K000737 | 000 |
| 04046964349089 | K000737 | 000 |
| 04046964349065 | K000737 | 000 |
| 20841268106967 | K000737 | 000 |