SPECTRANETICS VISISHEATH DILATOR SHEATH
FDA 510(k) clearance K092378 · decided 2009-11-02
Clearance details
- K-number
- K092378
- Device name
- SPECTRANETICS VISISHEATH DILATOR SHEATH
- Applicant
- Spectranetics Corp.
- Decision
- Substantially Equivalent
- Date received
- 2009-08-05
- Decision date
- 2009-11-02
- Days to decision
- 89 days
- Clearance type
- Traditional
- Product code
- DRE
- Device class
- 2
- Regulation number
- 870.1310
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Colorado Springs, CO, 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.
Recalls involving this device
No recalls on record reference this clearance.
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| AngioSculpt® Evo RX PTCA Scoring Balloon Catheter with Hydrophilic Coating (P050018/S033) | Spectranetics Corp. | 2023-10-19 |