PALMAZ GENESIS TRANSHEPATIC BILLARY STENT AND DELIVERY SYSTEM
FDA 510(k) clearance K010411 · decided 2001-08-27
Clearance details
- K-number
- K010411
- Device name
- PALMAZ GENESIS TRANSHEPATIC BILLARY STENT AND DELIVERY SYSTEM
- Applicant
- Cordis Corp.
- Decision
- Unknown
- Date received
- 2001-02-12
- Decision date
- 2001-08-27
- Days to decision
- 196 days
- Clearance type
- Abbreviated
- Product code
- FGE
- Device class
- 2
- Regulation number
- 876.5010
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Warren, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| This device is labeled as Sterile and is packaged in a Tyvek pouch with the following labe recall (Z-0567-04) | Cordis Corporation | 2004-07-20 |
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 |