STANICOR, OMNI-STAN,MOD 333B,334A GAMMA
FDA 510(k) clearance K792348 · decided 1979-12-05
Clearance details
- K-number
- K792348
- Device name
- STANICOR, OMNI-STAN,MOD 333B,334A GAMMA
- Applicant
- Cordis Corp.
- Decision
- Substantially Equivalent
- Date received
- 1979-11-19
- Decision date
- 1979-12-05
- Days to decision
- 16 days
- Clearance type
- Traditional
- Product code
- DTX
- Device class
- 2
- Regulation number
- 870.4300
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Cordis Corp.
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 |
|---|---|---|
| Quantum Mini Ventilation Module (K210669) | Spectrum Medical , Ltd. | 2021-05-04 |
| Quantum Ventilation Module (K202733) | Spectrum Medical , Ltd. | 2020-10-16 |
| Quantum Ventilation Module (K181942) | Spectrum Medical , Ltd. | 2018-10-18 |
| STOCKERT S5 SYSTEM AND GAS BLENDER AND SORIN C5 SYSTEM (K101046) | Sorin Group Deutschland GmbH | 2010-12-09 |
| SECHRIST AIR/OXYGEN MIXER, MODEL 3500 CP-G (K023745) | Sechrist Industries, Inc. | 2003-01-17 |
| COEUR FRONT LOAD INJECTOR RETROFIT KIT (C859-0002) (K965214) | Coeur Laboratories, Inc. | 1997-03-28 |
| MODIFIED SARNS MEMBRANE OXYGENATOR (K863902) | 3M Health Care, Sarns | 1986-12-11 |
| GAS-FLOW METER GFL 10 (K822820) | Gambro, Inc. | 1982-10-18 |
| FLOWMETER, OPTIFLO GAS (K790546) | Cobe Laboratories, Inc. | 1979-05-11 |
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 |