ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE, ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE
FDA 510(k) clearance K101651 · decided 2010-07-09
Clearance details
- K-number
- K101651
- Device name
- ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE, ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE
- Applicant
- Cordis Corp.
- Decision
- Substantially Equivalent
- Date received
- 2010-06-11
- Decision date
- 2010-07-09
- Days to decision
- 28 days
- Clearance type
- Special
- Product code
- NTE
- Device class
- 2
- Regulation number
- 870.1250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Bridgewater, NJ, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Cordis Corp.
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190) (K222694) | MicroVention, Inc. | 2023-04-27 |
| ENROUTE® Transcarotid Neuroprotection System (K230402) | Silk Road Medical | 2023-04-11 |
| ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture Guidewire (K220654) | Cordis Corporation | 2022-04-06 |
| WIRION Embolic Protection System (K210282) | Cardiovascular Systems, Inc. | 2021-03-03 |
| WIRION (K200198) | Cardiovascular Systems, Inc. | 2020-03-18 |
| Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery Wires (K191173) | Abbott Vascular | 2019-07-25 |
| WIRION (K180023) | Gardia Medical , Ltd. | 2018-03-21 |
| ENROUTE Transcarotid Neuroprotection System (K153485) | Silk Road Medical, Inc. | 2016-03-10 |
| RX ACCUNET Embolic Protection System (K153086) | Abbott Vascular | 2015-11-20 |
| WIRION (K143570) | Gardia Medical | 2015-06-04 |
| ENROUTE Transcarotid Neuroprotection System (K143072) | Silk Road Medical, Inc. | 2015-02-09 |
| EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM (K141678) | Abbott Vascular | 2014-07-22 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| CYPHER SIROLIMUS-ELUTING CORONARY STENT (P020026/S086) | Cordis Corp. | 2014-10-10 |
| CYPHER SIROLIMUS-ELUTING CORONARY STENT (P020026/S082) | Cordis Corp. | 2012-01-27 |
| CYPHER SIROLIMUS-ELUTING CORONARY STENT (P020026/S085) | Cordis Corp. | 2012-01-26 |
| CYPHER SIROLIMUS-ELUTING CORONARY STENT ON RAPTOR OVER-THE-WIRE DELIVERY SYSTEM/RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTE (P020026/S059) | Cordis Corp. | 2011-05-27 |
| CYPHER SIROLIMUS CORONARY STENT ON RAPTOR OTW DELIVERY SYSTEM OR RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM (CYPHER STENT (P020026/S083) | Cordis Corp. | 2011-05-27 |
| CYPHER SIROLIMUS-ELUTING CORONARY STENT ON RAPTOR OTW DELIVERY SYSTEM/RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM (CYPHER (P020026/S081) | Cordis Corp. | 2011-03-03 |
| CYPHER SIROLIMUS -ELUTING CORONARY STENT (4.0 MM) (P020026/S026) | Cordis Corp. | 2011-02-22 |
| CYPHER SIROLIMUS-ELUTING CORONARY STENT ON RAPTOR OTW DELIVERY SYSTEM/RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM (P020026/S078) | Cordis Corp. | 2010-09-02 |