The following data is part of a premarket notification filed by Medtronic Ps Medical with the FDA for Medtronic Ps Medical Innervision Ventricular Catheter, 15cm Model 99102.
| Device ID | K983331 |
| 510k Number | K983331 |
| Device Name: | MEDTRONIC PS MEDICAL INNERVISION VENTRICULAR CATHETER, 15CM MODEL 99102 |
| Classification | Catheter, Ventricular |
| Applicant | MEDTRONIC PS MEDICAL 125 CREMONA DR. Goleta, CA 93117 -5500 |
| Contact | Jeffrey Henderson |
| Correspondent | Jeffrey Henderson MEDTRONIC PS MEDICAL 125 CREMONA DR. Goleta, CA 93117 -5500 |
| Product Code | HCA |
| CFR Regulation Number | 882.4100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-22 |
| Decision Date | 1998-12-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994966018 | K983331 | 000 |
| 00643169483828 | K983331 | 000 |
| 00643169483811 | K983331 | 000 |
| 00643169472860 | K983331 | 000 |
| 00643169472723 | K983331 | 000 |
| 00721902992247 | K983331 | 000 |
| 00763000030926 | K983331 | 000 |
| 00763000029920 | K983331 | 000 |
| 00763000029913 | K983331 | 000 |
| 00763000029906 | K983331 | 000 |
| 00763000029890 | K983331 | 000 |
| 00763000029883 | K983331 | 000 |
| 00763000029876 | K983331 | 000 |
| 00763000029869 | K983331 | 000 |
| 00763000028848 | K983331 | 000 |
| 00643169483835 | K983331 | 000 |
| 00643169483842 | K983331 | 000 |
| 00613994965998 | K983331 | 000 |
| 00613994965981 | K983331 | 000 |
| 00613994965974 | K983331 | 000 |
| 00613994965950 | K983331 | 000 |
| 00613994965943 | K983331 | 000 |
| 00613994965738 | K983331 | 000 |
| 00643169499249 | K983331 | 000 |
| 00643169498082 | K983331 | 000 |
| 00643169496835 | K983331 | 000 |
| 00643169483897 | K983331 | 000 |
| 00643169483880 | K983331 | 000 |
| 00643169483873 | K983331 | 000 |
| 00643169483866 | K983331 | 000 |
| 00643169483859 | K983331 | 000 |
| 00763000028961 | K983331 | 000 |