Product code LKG
- Device name
- Port & Catheter, Implanted, Subcutaneous, Intraventricular
- Medical specialty
- Neurology
- Device class
- 2
- Regulation number
- 882.5550
- Review panel
- HO
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K950315 | CORDIS CSF RESERVOIR | Cordis Corp. | 1995-05-09 |
| K881493 | PORT-A-CATH IMPLANTABLE ACCESS SYSTEM - KIT CONF. | Pharmacia Deltec, Inc. | 1988-05-20 |
| K881690 | PORT-A-CATH PORTAL INTRODUCER FORCEPS | Pharmacia Deltec, Inc. | 1988-05-20 |
| K874468 | P-S MEDICAL VENTRICULAR ACCESS PORT | Pudenz-Schulte Medical Research Corp. | 1988-02-11 |
| K874498 | CSF-VENTRICULOSTOMY RESERVOIR | Pudenz-Schulte Medical Research Corp. | 1988-02-11 |
| K833822 | P-S MEDICAL CSF ACCESS DEV 15MM/25MM | Pudenz-Schulte Medical Research Corp. | 1984-05-25 |
| K833672 | HH SUBCUTANEOUS ACCESS PORT | Holter-Hausner Intl. | 1984-03-06 |
| K823790 | VENTRICULAR ACCESS SYSTEM | American Heyer Schulte | 1983-04-28 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00763000980863 | Reservoir | Micro Therapeutics, Inc. | 2025-08-03 |
| 00763000980849 | Reservoir | MEDTRONIC POWERED SURGICAL SOLUTIONS | 2025-08-03 |
| 00763000980856 | Reservoir | MEDTRONIC POWERED SURGICAL SOLUTIONS | 2025-07-31 |
| 00763000028268 | N/A | MEDTRONIC PS MEDICAL, INC. | 2020-04-20 |
| 00763000028275 | N/A | MEDTRONIC PS MEDICAL, INC. | 2020-04-19 |
| 00763000030612 | N/A | Micro Therapeutics, Inc. | 2020-04-19 |
| 00763000030636 | N/A | MEDTRONIC POWERED SURGICAL SOLUTIONS | 2020-04-19 |
| 00763000031107 | N/A | MEDTRONIC POWERED SURGICAL SOLUTIONS | 2020-04-19 |
| 00382830055772 | Natus® | NATUS MEDICAL INCORPORATED | 2020-04-03 |
| 00382830055826 | Natus® | NATUS MEDICAL INCORPORATED | 2020-04-03 |
| 00382830056212 | Natus® | NATUS MEDICAL INCORPORATED | 2020-04-03 |
| 00763000028251 | N/A | MEDTRONIC PS MEDICAL, INC. | 2020-03-20 |
| 00763000028503 | N/A | MEDTRONIC PS MEDICAL, INC. | 2020-03-20 |
| 00763000028244 | N/A | MEDTRONIC PS MEDICAL, INC. | 2020-03-20 |
| 00763000028237 | N/A | MEDTRONIC PS MEDICAL, INC. | 2020-03-20 |
| 00763000028510 | N/A | MEDTRONIC PS MEDICAL, INC. | 2020-03-20 |
| 00763000028527 | N/A | MEDTRONIC PS MEDICAL, INC. | 2020-03-20 |
| 00763000028534 | N/A | MEDTRONIC PS MEDICAL, INC. | 2020-03-20 |
| 00763000029197 | N/A | MEDTRONIC PS MEDICAL, INC. | 2020-03-20 |
| 10381780034605 | CSF Reservoir | INTEGRA NEUROSCIENCES IMPLANT (FRANCE) | 2015-10-01 |
| 10381780034612 | CSF Reservoir | INTEGRA NEUROSCIENCES IMPLANT (FRANCE) | 2015-10-01 |
| 10381780034599 | CSF Reservoir | INTEGRA NEUROSCIENCES IMPLANT (FRANCE) | 2015-10-01 |
| 10381780034582 | CSF Reservoir | INTEGRA NEUROSCIENCES IMPLANT (FRANCE) | 2015-10-01 |
| 00643169497528 | NA | Micro Therapeutics, Inc. | 2015-07-07 |
| 00643169497542 | NA | MEDTRONIC POWERED SURGICAL SOLUTIONS | 2015-07-07 |
| 00643169579385 | NA | MEDTRONIC POWERED SURGICAL SOLUTIONS | 2015-06-24 |
| 00673978235578 | NA | MEDTRONIC PS MEDICAL, INC. | 2015-06-17 |
| 00613994908674 | NA | MEDTRONIC POWERED SURGICAL SOLUTIONS | 2015-06-17 |
| 00613994908308 | NA | MEDTRONIC POWERED SURGICAL SOLUTIONS | 2015-06-16 |
| 00613994908285 | NA | Micro Therapeutics, Inc. | 2015-06-16 |