MODIFICATION TO EXPORT ASPIRATION CATHETER
FDA 510(k) clearance K030201 · decided 2003-03-26
Clearance details
- K-number
- K030201
- Device name
- MODIFICATION TO EXPORT ASPIRATION CATHETER
- Applicant
- Medtronic Vascular
- Decision
- Substantially Equivalent
- Date received
- 2003-01-21
- Decision date
- 2003-03-26
- Days to decision
- 64 days
- Clearance type
- Special
- Product code
- NFA
- 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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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| INTERCEPTOR PLUS CORONARY FILTER SYSTEMS (K073523) | Medtronic, Inc. | 2008-08-01 |
| MODIFICATION TO PROXIS SYSTEM (K073563) | St Jude Medical | 2008-01-31 |
| SPIDERFX EMBOLIC PROTECTION DEVICE (K063785) | Ev3, Inc. | 2007-01-19 |
| TRIACTIV FX EMBOLIC PROTECTION SYSTEM, MODEL PN 60040-02; -03 (K062870) | Kensey Nash Corp. | 2006-10-20 |
| PROXIS SYSTEM, MODEL EPS101 (K060651) | St Jude Medical | 2006-09-13 |
| PROXIS SYSTEM (K052523) | Velocimed, Inc. | 2006-09-07 |
| SPIDERX EMBOLIC PROTECTION DEVICE (K062201) | Ev3, Inc. | 2006-08-11 |
| FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM (2.25 MM-3.5 MM) (K061332) | Boston Scientific Corp | 2006-08-11 |
| TRIACTIV FX EMBOLIC PROTECTION SYSTEM (K061772) | Kensey Nash Corp. | 2006-07-11 |
| SPIDERX EMBOLIC PROTECTION DEVICE (K053195) | Ev3, Inc. | 2006-06-23 |
| FILTERWIRE EZ (2.25 MM - 3.5 MM) EMBOLIC PROTECTION SYSTEM, MODELS 20120-190, 20120-300 (K051984) | Boston Scientific Corp | 2006-04-10 |
| FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM (K052280) | Boston Scientific Corp | 2005-11-07 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Resolute Onyx Zotarolimus-Eluting Coronary Stent System - RX and OTW; Onyx Frontier Zotarolimus-Eluting Coronary Stent S (P160043/S089) | Medtronic Vascular | 2025-12-19 |
| Endurant II/IIs Stent Graft System (P100021/S131) | Medtronic Vascular | 2025-10-23 |
| Endurant Stent Graft System, Endurant II Stent Graft System, Endurant IIs Stent Graft System (P100021/S129) | Medtronic Vascular | 2025-09-15 |
| Resolute Onyx (P160043/S088) | Medtronic Vascular | 2025-06-26 |
| Endurant Stent Graft System (P100021/S130) | Medtronic Vascular | 2025-06-12 |
| Valiant Thoracic Stent Graft with the Captivia Delivery System (P100040/S073) | Medtronic Vascular | 2025-06-12 |
| Valiant Thoracic Stent Graft with the Captivia Delivery System (P100040/S072) | Medtronic Vascular | 2025-05-20 |
| Valiant Thoracic Stent Graft with the Captiva Delivery System (P100040/S069) | Medtronic Vascular | 2025-05-08 |