MEDTRONIC 5F & 9F ZUMA GUIDING CATHETERS
FDA 510(k) clearance K990707 · decided 1999-03-22
Clearance details
- K-number
- K990707
- Device name
- MEDTRONIC 5F & 9F ZUMA GUIDING CATHETERS
- Applicant
- Medtronics Interventional Vascular
- Decision
- Substantially Equivalent
- Date received
- 1999-03-04
- Decision date
- 1999-03-22
- Days to decision
- 18 days
- Clearance type
- Special
- Product code
- DQY
- Device class
- 2
- Regulation number
- 870.1250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Danvers, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| 5F ZUMA SR3.0 CATHETER ZM5SR30 Z2 5F 100CM SR30 Coronary Guiding catheter designed to prov recall (Z-1054-06) | Medtronic, Inc. | 2006-06-01 |
| ZM5SR35 5F ZUMA SR3.5 CATHETER ZM5SR35 Z2 5F 100CM SR35 Coronary Guiding catheter designed recall (Z-1055-06) | Medtronic, Inc. | 2006-06-01 |
| 5F ZUMA SR4.0 CATHETER ZM5SR40 Z2 5F 100CM SR40 Coronary Guiding catheter designed to prov recall (Z-1056-06) | Medtronic, Inc. | 2006-06-01 |
| 5F ZUMA SR5.0 Coronary Guiding catheter designed to provide a pathway through which therap recall (Z-1057-06) | Medtronic, Inc. | 2006-06-01 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| THE MEDTRONIC ACHIEVER CORONARY BALLON DILATION CATHETER (P870036/S044) | Medtronics Interventional Vascular | 1998-11-17 |
| MEDTRONIC WIKTOR RIVAL CORONARY STENT SYSTEM (P960010/S001) | Medtronics Interventional Vascular | 1998-05-21 |
| MEDTRONIC(R)MILLENIA TM 15 CORONARY BALLOON DILATATION CATHETER (P870036/S043) | Medtronics Interventional Vascular | 1997-08-12 |
| MEDTRONIC(R) MS2(TM) BALLOON SHAPING TOOL (P870036/S042) | Medtronics Interventional Vascular | 1997-07-28 |
| MEDTRONIC WIKTOR PRIME CORONARY STENT DELIVERY SYSTEM (P960010) | Medtronics Interventional Vascular | 1997-06-27 |
| MEDTRONIC(R) EVERGREEN(TM) CORONARY BALLOON DILATATION CATHETERS (P870036/S041) | Medtronics Interventional Vascular | 1997-03-07 |
| MEDTRONIC(R) FALCON(R) CORONARY BALLOON DILATATION CATHETERS (P870036/S040) | Medtronics Interventional Vascular | 1996-10-25 |
| MEDTRONIC(R) MILLENIA (TM) FAMILY OF CORONARY BALLOON DILATATION CATHETERS (P870036/S038) | Medtronics Interventional Vascular | 1996-09-25 |