SURGIVISION MR COMPATIBLE VENTRICULAR CANNULA
FDA 510(k) clearance K102101 · decided 2011-01-26
Clearance details
- K-number
- K102101
- Device name
- SURGIVISION MR COMPATIBLE VENTRICULAR CANNULA
- Applicant
- Surgivision, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-07-27
- Decision date
- 2011-01-26
- Days to decision
- 183 days
- Clearance type
- Traditional
- Product code
- HCD
- Device class
- 1
- Regulation number
- 882.4060
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Irvine, CA, 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 |
|---|---|---|
| Alcyone MEMS Cannula (AMC) System (K150660) | Alcyone Lifesciences, Inc. | 2015-04-16 |
| CAMINO VENTRICULAR NEEDLE (K920088) | Camino Laboratories, Inc. | 1992-05-01 |
Recalls involving this device
No recalls on record reference this clearance.