The following data is part of a premarket notification filed by Numed, Inc. with the FDA for Numed Atrioseptostomy Catheter.
| Device ID | K960070 |
| 510k Number | K960070 |
| Device Name: | NUMED ATRIOSEPTOSTOMY CATHETER |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | NUMED, INC. MAIN ST. Hopkinton, NY 12940 |
| Contact | Susan D Jones |
| Correspondent | Susan D Jones NUMED, INC. MAIN ST. Hopkinton, NY 12940 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-01-05 |
| Decision Date | 1996-04-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04046964333811 | K960070 | 000 |
| 04046964333439 | K960070 | 000 |