MEDTRONIC PS MEDICAL NIVEAU DRAINAGE SYSTEM, MEDTRONIC PS MEDICAL NIVEAU DRAINAGE SYSTEM POLE CLAMP, MEDTRONIC PS MEDICL
FDA 510(k) clearance K983799 · decided 1999-01-26
Clearance details
- K-number
- K983799
- Device name
- MEDTRONIC PS MEDICAL NIVEAU DRAINAGE SYSTEM, MEDTRONIC PS MEDICAL NIVEAU DRAINAGE SYSTEM POLE CLAMP, MEDTRONIC PS MEDICL
- Applicant
- Medtronic PS Medical
- Decision
- Substantially Equivalent
- Date received
- 1998-10-28
- Decision date
- 1999-01-26
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- GWM
- Device class
- 2
- Regulation number
- 882.1620
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Goleta, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Medtronic PS Medical
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API,
or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|
| Pressio 3 Multi-parameter Neuromonitoring System (K252241) | Sophysa | 2026-04-10 |
| NEUROVENT-P (092946-003); NEUROVENT (092956-003); NEUROVENT-IFD-R (095317-003); NEUROVENT-IFD-S (091678-003); NEUROVENT-P-TEMP (094268-003); NEUROVENT-TEMP (094278-003); NEUROVENT-TEMP-IFD-R (095327-003); NEUROVENT-TEMP-IFD-S (094288-003); NEUROVENT-PTO (095008-003); NEUROVENT-PTO 2L (095108-003); NEUROVENT-PX (091580-003); BOLT-DRILL KIT CH5 (091888-003); BOLT-DRILL KIT CH9 (091898-003); BOLT-DRILL KIT PTO (092380-003); BOLT-DRILL KIT VP 16 (092969-003); BOLT KIT CH5 (091868-003); BOL (K250285) | Raumedic AG | 2025-08-29 |
| B4C System - Addition of new sensor model (BcSs-PICNIW-2000) (K240821) | Braincare Desenvolvimento E Inovação Tecnológica S.A. | 2024-07-18 |
| CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845) (K232890) | Integra Lifesciences Production Corporation | 2024-02-04 |
| B4C System (K201989) | Braincare Desenvolvimento E Inovacao Tecnologica S.A. | 2021-10-08 |
| CereLink ICP Monitor (K210993) | Integra Lifesciences Production Corporation | 2021-04-30 |
| Exacta External Drainage and Monitoring System, Exacta Pole with Laser Level, Exacta System Replacement Drainage Bag, Replacement Laser Level (K201118) | Medtronic, Inc. | 2020-05-26 |
| Medtronic External Drainage and Monitoring System, Medtronic External Drainage and Monitoring System, Becker Replacement Drainage Bags (K200630) | Medtronic, Inc. | 2020-04-09 |
| Becker External Drainage and Monitoring System (K200456) | Medtronic, Inc. | 2020-03-26 |
| BcSs-PICNI-2000 Sensor (K182073) | Braincare Desenvolvimento E Inovacao Tecnologica S.A. | 2019-10-17 |
| CereLink ICP Monitor, CereLink ICP Extension Cable (K183406) | Integra Lifesciences Corp. | 2019-01-11 |
| AURA ICP MONITORING SYSTEM (K172209) | Branchpoint Technologies, Inc. | 2018-05-18 |
Recalls involving this device
No recalls on record reference this clearance.