DESERET EPIDURAL CATHETER W/TOUGHY-BORST ADAPTER
FDA 510(k) clearance K850505 · decided 1985-03-11
Clearance details
- K-number
- K850505
- Device name
- DESERET EPIDURAL CATHETER W/TOUGHY-BORST ADAPTER
- Applicant
- Parke-Davis Co.
- Decision
- Substantially Equivalent
- Date received
- 1985-02-08
- Decision date
- 1985-03-11
- Days to decision
- 31 days
- Clearance type
- Traditional
- Product code
- BSO
- Device class
- 2
- Regulation number
- 868.5120
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Rochester, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| BD Perisafe catheter with catheter connector. The catheter connector has four components: recall (Z-0467-06) | Becton Dickinson & Company | 2006-02-04 |
| BD Perisafe epidural mini-kit: 18 G x 3 1/2 in. Weiss needle. The catheter connector has f recall (Z-0468-06) | Becton Dickinson & Company | 2006-02-04 |