ALLIGATOR RETRIEVAL DEVICE (ARD)
FDA 510(k) clearance K043580 · decided 2005-03-24
Clearance details
- K-number
- K043580
- Device name
- ALLIGATOR RETRIEVAL DEVICE (ARD)
- Applicant
- Chestnut Medical Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-12-28
- Decision date
- 2005-03-24
- Days to decision
- 86 days
- Clearance type
- Traditional
- Product code
- DQY
- Device class
- 2
- Regulation number
- 870.1250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Palo Alto, CA, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Alligator Retrieval Device (ARD). Used in the peripheral and neurovasculature for foreign recall (Z-1454-2014) | Micro Therapeutics Inc, Dba Ev3 Neurovascular | 2014-04-16 |