VARIOUS-SPECIMEN COLLECTORS
FDA 510(k) clearance K823763 · decided 1983-01-19
Clearance details
- K-number
- K823763
- Device name
- VARIOUS-SPECIMEN COLLECTORS
- Applicant
- Cordis Corp.
- Decision
- Substantially Equivalent
- Date received
- 1982-12-14
- Decision date
- 1983-01-19
- Days to decision
- 36 days
- Clearance type
- Traditional
- Product code
- FMH
- Device class
- 1
- Regulation number
- 864.3250
- Medical specialty
- Pathology
- Advisory committee
- Pathology
- Location
- Walker, MI, 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 |
|---|---|---|
| TRI-TECH URINE SPECIMEN KIT (K900983) | Tri-Tech, Inc. | 1990-09-17 |
| CALCULI FILTER CUP (K820180) | Omnimedical | 1982-02-05 |
| LANCER SPECIMEN CONTAINER (K812933) | Sherwood Medical Co. | 1981-11-06 |
| SPECIMEN SET (K802340) | American Pharmaseal Div. Ahsc | 1980-10-10 |
| URINE SPECIMEN CONTAINER #'S 1013-1016 (K802002) | Pollak (Intl.), Ltd. | 1980-09-09 |
| MIDSTREAM COLLECTION KIT (K800947) | Sage Products, Inc. | 1980-05-30 |
| SPECIMEN COLLECTION PAN (K800309) | Sage Products, Inc. | 1980-02-26 |
| ABCO MIDSTREAM URINE COLLECTION SET (K800233) | Abco Dealers, Inc. | 1980-02-26 |
| PARA-PAK CLEAN VIAL (K792710) | Meridian Diagnostics, Inc. | 1980-01-28 |
| LANCER SPECIMEN CONTAINER (K792156) | Sherwood Medical Co. | 1979-12-10 |
| SPECIMAN CUP & EMESIS BASIN (K792211) | General Clinical Plastics Corp. | 1979-11-16 |
| JUHN TYM-TAP (K790915) | Xomed, Inc. | 1979-06-27 |
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 |