The following data is part of a premarket notification filed by Medtronic Ps Medical with the FDA for Medtronic Ps Medical External Drainage And Monitoring (edm) Ventricular Catheter, 20cm And 35 Cm Model # 96115 And 96118.
| Device ID | K981046 |
| 510k Number | K981046 |
| Device Name: | MEDTRONIC PS MEDICAL EXTERNAL DRAINAGE AND MONITORING (EDM) VENTRICULAR CATHETER, 20CM AND 35 CM MODEL # 96115 AND 96118 |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | MEDTRONIC PS MEDICAL 125 CREMONA DR. Goleta, CA 93117 -5500 |
| Contact | Richard M Ruedy |
| Correspondent | Richard M Ruedy MEDTRONIC PS MEDICAL 125 CREMONA DR. Goleta, CA 93117 -5500 |
| Product Code | JXG |
| CFR Regulation Number | 882.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-20 |
| Decision Date | 1998-06-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169498211 | K981046 | 000 |
| 00763000406035 | K981046 | 000 |
| 00763000028749 | K981046 | 000 |
| 00763000030711 | K981046 | 000 |
| 00763000030759 | K981046 | 000 |
| 00763000181611 | K981046 | 000 |
| 00643169472570 | K981046 | 000 |
| 00643169497184 | K981046 | 000 |
| 00643169498129 | K981046 | 000 |
| 00643169498167 | K981046 | 000 |
| 00763000875923 | K981046 | 000 |