The following data is part of a premarket notification filed by Catheter Research, Inc. with the FDA for H/s Catheter Set.
| Device ID | K032835 |
| 510k Number | K032835 |
| Device Name: | H/S CATHETER SET |
| Classification | Cannula, Manipulator/injector, Uterine |
| Applicant | CATHETER RESEARCH, INC. 6131 WEST 80TH ST. Indianapolis, IN 46278 |
| Contact | John A Steen |
| Correspondent | John A Steen CATHETER RESEARCH, INC. 6131 WEST 80TH ST. Indianapolis, IN 46278 |
| Product Code | LKF |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-11 |
| Decision Date | 2003-12-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00690521009325 | K032835 | 000 |
| 10852073002095 | K032835 | 000 |
| 10852073002071 | K032835 | 000 |
| 10852073002064 | K032835 | 000 |
| 10852073002057 | K032835 | 000 |
| 10852073002040 | K032835 | 000 |
| 00852073002814 | K032835 | 000 |
| M803TMI20002 | K032835 | 000 |
| M803TMI1199 | K032835 | 000 |
| M803TMI1198 | K032835 | 000 |
| M803TMI1188 | K032835 | 000 |
| M803TMI1187 | K032835 | 000 |
| M803TMI1185 | K032835 | 000 |
| M803TMI1162 | K032835 | 000 |
| M803TMI1161 | K032835 | 000 |
| M803TMI1160 | K032835 | 000 |
| M803TMI1157 | K032835 | 000 |
| M803TMI1155 | K032835 | 000 |
| 10852073002347 | K032835 | 000 |
| 10852073002354 | K032835 | 000 |
| 00852073002548 | K032835 | 000 |
| 00690521009318 | K032835 | 000 |
| 10852073002996 | K032835 | 000 |
| 10852073002989 | K032835 | 000 |
| 10852073002897 | K032835 | 000 |
| 00852073002883 | K032835 | 000 |
| 00852073002876 | K032835 | 000 |
| 10852073002859 | K032835 | 000 |
| 10852073002842 | K032835 | 000 |
| 10852073002835 | K032835 | 000 |
| 10852073002828 | K032835 | 000 |
| 1085207300281 | K032835 | 000 |
| 00852073002708 | K032835 | 000 |
| 10852073002613 | K032835 | 000 |
| 10852073002606 | K032835 | 000 |
| 10852073002576 | K032835 | 000 |
| 10852073002569 | K032835 | 000 |
| 00852073002555 | K032835 | 000 |
| M803TMI1154 | K032835 | 000 |