Ep Technologies, Inc.
San Jose, CA, US
Ep Technologies, Inc. appears in FDA device records in San Jose, CA. FDA records list 15 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 15
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 15 510(k) clearances for Ep Technologies, Inc. between 1988 and 2005. The busiest year on record is 1990, with 4. The most recent is 2005, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1988 | 1 |
| 1989 | 2 |
| 1990 | 4 |
| 1991 | 1 |
| 1993 | 2 |
| 1994 | 2 |
| 2000 | 1 |
| 2002 | 1 |
| 2005 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K043257 | REAL-TIME POSITION MANAGEMENT (RPM) SYSTEM | DRF | Substantially Equivalent | |
| K013349 | ASTRONOMER PLUS SYSTEM | DQK | Substantially Equivalent | |
| K003452 | POLARIS X CATHETERS, MODEL 7000D,7001D,7003D,7004D,7005D,7006D | DRF | Substantially Equivalent | |
| K940167 | DIAGNOSTIC I CATHETER | DRF | Substantially Equivalent | |
| K940168 | DIAGNOSTIC II CATHETER | DRF | Substantially Equivalent | |
| K924109 | STEEROCATH II | DRF | Substantially Equivalent | |
| K924108 | TRACFINDER II | DRF | Substantially Equivalent | |
| K913375 | TORQUE TUBE STEEROCATH(TM) | DRF | Substantially Equivalent | |
| K903880 | FRANZ(TM) STEERABLE COMBINATION CATHETER | DRF | Substantially Equivalent | |
| K900765 | STEEROCATH(TM) | DRF | Substantially Equivalent | |
| K900452 | QUATTRO CATHETER | DRF | Substantially Equivalent | |
| K900553 | CONSTANT CURRENT STIMULATOR MODEL 022101 | JOQ | Substantially Equivalent | |
| K892207 | FRANZ(TM) MOVEABLE STYLET MAP CATHETER, MODIFIED | DRF | Substantially Equivalent | |
| K885252 | MAP DC-COUPLED ISOLATED PREAMPLIFIER MODEL #1001 | DRQ | Substantially Equivalent | |
| K881853 | FRANZ CATHETER | DRF | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain