EXPLORER/360-POLARIS-L.E./JACKMAN CORON SINUS ELEC
FDA 510(k) clearance K924163 · decided 1993-09-03
Clearance details
- K-number
- K924163
- Device name
- EXPLORER/360-POLARIS-L.E./JACKMAN CORON SINUS ELEC
- Applicant
- Boston Scientific Corp
- Decision
- Substantially Equivalent
- Date received
- 1992-08-19
- Decision date
- 1993-09-03
- Days to decision
- 380 days
- Clearance type
- Traditional
- Product code
- DRF
- Device class
- 2
- Regulation number
- 870.1220
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- San Jose, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Polaris Dx Diagnostic Catheter, for cardiac electrophysiology studies, Model M0049663S0 recall (Z-1191-2007) | Boston Scientific Corp | 2007-08-22 |