FOURSNARE VASCULAR RETRIEVAL SNARE
FDA 510(k) clearance K112185 · decided 2011-11-02
Clearance details
- K-number
- K112185
- Device name
- FOURSNARE VASCULAR RETRIEVAL SNARE
- Applicant
- Cook, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-07-29
- Decision date
- 2011-11-02
- Days to decision
- 96 days
- Clearance type
- Traditional
- Product code
- MMX
- Device class
- 2
- Regulation number
- 870.5150
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Bloomington, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| CloverSnare 4-Loop Vascular Retrieval Snare. Product is packaged in a Tyvek-film steriliza recall (Z-2243-2014) | Cook Inc. | 2014-08-27 |
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|---|---|---|
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| Zenith® Fenestrated AAA Endovascular Graft (ZFEN), Zenith® Flex AAA Endovascular System (P020018/S062) | Cook, Inc. | 2023-12-13 |
| Zenith Fenestrated AAA Endovascular Graft (P020018/S060) | Cook, Inc. | 2022-01-20 |
| Zenith AAA Endovascular Graft (P020018/S059) | Cook, Inc. | 2020-10-08 |
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