CORDIS CSF RESERVOIR
FDA 510(k) clearance K950315 · decided 1995-05-09
Clearance details
- K-number
- K950315
- Device name
- CORDIS CSF RESERVOIR
- Applicant
- Cordis Corp.
- Decision
- Unknown
- Date received
- 1995-01-26
- Decision date
- 1995-05-09
- Days to decision
- 103 days
- Clearance type
- Traditional
- Product code
- LKG
- Device class
- 2
- Regulation number
- 882.5550
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Miami, FL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| PORT-A-CATH PORTAL INTRODUCER FORCEPS (K881690) | Pharmacia Deltec, Inc. | 1988-05-20 |
| PORT-A-CATH IMPLANTABLE ACCESS SYSTEM - KIT CONF. (K881493) | Pharmacia Deltec, Inc. | 1988-05-20 |
| P-S MEDICAL VENTRICULAR ACCESS PORT (K874468) | Pudenz-Schulte Medical Research Corp. | 1988-02-11 |
| CSF-VENTRICULOSTOMY RESERVOIR (K874498) | Pudenz-Schulte Medical Research Corp. | 1988-02-11 |
| P-S MEDICAL CSF ACCESS DEV 15MM/25MM (K833822) | Pudenz-Schulte Medical Research Corp. | 1984-05-25 |
| HH SUBCUTANEOUS ACCESS PORT (K833672) | Holter-Hausner Intl. | 1984-03-06 |
| VENTRICULAR ACCESS SYSTEM (K823790) | American Heyer Schulte | 1983-04-28 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| CYPHER SIROLIMUS-ELUTING CORONARY STENT (P020026/S086) | Cordis Corp. | 2014-10-10 |
| CYPHER SIROLIMUS-ELUTING CORONARY STENT (P020026/S082) | Cordis Corp. | 2012-01-27 |
| CYPHER SIROLIMUS-ELUTING CORONARY STENT (P020026/S085) | Cordis Corp. | 2012-01-26 |
| CYPHER SIROLIMUS-ELUTING CORONARY STENT ON RAPTOR OVER-THE-WIRE DELIVERY SYSTEM/RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTE (P020026/S059) | Cordis Corp. | 2011-05-27 |
| CYPHER SIROLIMUS CORONARY STENT ON RAPTOR OTW DELIVERY SYSTEM OR RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM (CYPHER STENT (P020026/S083) | Cordis Corp. | 2011-05-27 |
| CYPHER SIROLIMUS-ELUTING CORONARY STENT ON RAPTOR OTW DELIVERY SYSTEM/RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM (CYPHER (P020026/S081) | Cordis Corp. | 2011-03-03 |
| CYPHER SIROLIMUS -ELUTING CORONARY STENT (4.0 MM) (P020026/S026) | Cordis Corp. | 2011-02-22 |
| CYPHER SIROLIMUS-ELUTING CORONARY STENT ON RAPTOR OTW DELIVERY SYSTEM/RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM (P020026/S078) | Cordis Corp. | 2010-09-02 |