FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ASTRONOMER PLUS SYSTEM
K Number: K013349
·
Decision Apr 9, 2002
Classifications
1
FEI Numbers
178
Registration Numbers
178
Same Product Code
429
Applicant Total
15
Review Days
182
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
- ASTRONOMER PLUS SYSTEM
- K Number
- K013349
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 870.1425
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ep Technologies, Inc.
- Date Received
- October 9, 2001
- Decision Date
- April 9, 2002
- Product Code
- DQK
- 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 |
|---|---|---|---|
| DQK | Computer, Diagnostic, Programmable | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DQK), ordered by most recent decision date.
OneStim-DUO Cardiac Stimulator (MP5003-4CO)
FDA 510(k)
FDA Class 2
·Cardiovascular
Intra-Operative Positioning System (IOPS) (MC-1);IOPS Viewpoint Simple Curve Catheter, 75cm (C00751);IOPS Viewpoint Simple Curve Catheter, 125cm (C01251);IOPS Viewpoint Double Curve Catheter, 75cm (C00752);IOPS Viewpoint Double Curve Catheter, 125cm (C02152);IOPS Guidewire 2 (ATW-2);IOPS Fiducial Tracking Pad (T02111);IOPS Guidewire Handle (H01035)
FDA 510(k)
FDA Class 2
·Cardiovascular
ZEUS Platform (FG0501US)
FDA 510(k)
FDA Class 2
·Cardiovascular
EnSite X EP System
FDA 510(k)
FDA Class 2
·Cardiovascular
ACORYS MAPPING SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
Synchrony
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 |
| 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 |
| K913375 | TORQUE TUBE STEEROCATH(TM) | Oct 25, 1991 | 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 |