OMNICOR PROGRAMMER MODEL 222A
FDA 510(k) clearance K771855 · decided 1977-10-07
Clearance details
- K-number
- K771855
- Device name
- OMNICOR PROGRAMMER MODEL 222A
- Applicant
- Cordis Corp.
- Decision
- Substantially Equivalent
- Date received
- 1977-09-28
- Decision date
- 1977-10-07
- Days to decision
- 9 days
- Clearance type
- Traditional
- Product code
- KRG
- Device class
- 3
- Regulation number
- 870.3700
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Mchenry, IL, 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 |
|---|---|---|
| INTERMEDICS TRIANGLE CHEST PROBE MODEL 526-04 (K933278) | Intermedics, Inc. | 1995-03-15 |
| MODEL 5650 OPTIMATE PERSONAL PROGRAMMER (K884522) | Teletronics, Inc. | 1989-08-25 |
| MODEL 2331T PATIENT PROGRAMMER (K880738) | Medtronic Vascular | 1988-11-17 |
| MODEL 255A PROGRAMMER III, W/SOFTWARE REVI. 4004 (K882429) | Tpl-Cordis, Inc. | 1988-07-22 |
| MODEL 1740 PERSONAL POCKET PROGRAMMER (K864712) | Telectronics, Inc. | 1987-12-17 |
| MODEL 5600B PROGRAMMER, PACEMAKER (K871986) | Telectronics, Inc. | 1987-06-24 |
| ULTRA SOFTWARE MODULE: MODEL 2016 (K863046) | Cardiac Pacemakers, Inc. | 1986-12-05 |
| PROGRAMMER MODEL 2035/ELECTROGRAM CABLE MODEL 6580 (K863045) | Cardiac Pacemakers, Inc. | 1986-09-29 |
| SOFTWARE MODULE/2035 PROG AND ASTRA/T PULSE GEN (K860584) | Cardiac Pacemakers, Inc. | 1986-06-06 |
| DIALOG PROGRAMMER 700 - PROGRAM VERSION 6.37 (K860546) | Pacesetter Systems | 1986-04-23 |
| HEWLETT PACKARDT HP 85 W/ VITATRON PH1 PROGRAM HEA (K844484) | Vitatron Medical BV | 1985-07-24 |
| CERYX6, 611, CERYX 3 311 & CERYX 1 111 (K844485) | Vitatron Medical BV | 1985-04-19 |
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 |