FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TORQUE TUBE STEEROCATH(TM)
K Number: K913375
·
Decision Oct 25, 1991
Classifications
1
FEI Numbers
88
Registration Numbers
88
Same Product Code
184
Applicant Total
15
Review Days
88
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- TORQUE TUBE STEEROCATH(TM)
- K Number
- K913375
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1220
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Ep Technologies, Inc.
- Date Received
- July 29, 1991
- Decision Date
- October 25, 1991
- Product Code
- DRF
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DRF), ordered by most recent decision date.
Vision-MR Diagnostic Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
MAGiC Sweep EP Mapping Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
VIKING Fixed Curve Diagnostic Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
EPXT Unidirectional Steerable Diagnostic Catheter; Dynamic Tip Unidirectional Steerable Diagnostic Catheter; Dynamic XT Unidirectional Steerable Diagnostic Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Nordica PV Cryo Mapping Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Cosine-10TM Diagnostic Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Ep Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K043257 | REAL-TIME POSITION MANAGEMENT (RPM) SYSTEM | Feb 3, 2005 | Substantially Equivalent |
| K013349 | ASTRONOMER PLUS SYSTEM | Apr 9, 2002 | Substantially Equivalent |
| K003452 | POLARIS X CATHETERS, MODEL 7000D,7001D,7003D,7004D,7005D,7006D | Dec 7, 2000 | Substantially Equivalent |
| K940167 | DIAGNOSTIC I CATHETER | Aug 2, 1994 | Substantially Equivalent |
| K940168 | DIAGNOSTIC II CATHETER | Jul 27, 1994 | Substantially Equivalent |
| K924108 | TRACFINDER II | Dec 16, 1993 | Substantially Equivalent |
| K924109 | STEEROCATH II | Dec 16, 1993 | Substantially Equivalent |
| K903880 | FRANZ(TM) STEERABLE COMBINATION CATHETER | Oct 12, 1990 | Substantially Equivalent |
| K900765 | STEEROCATH(TM) | May 7, 1990 | Substantially Equivalent |
| K900452 | QUATTRO CATHETER | Mar 14, 1990 | Substantially Equivalent |