CATHETERS, BILIARY CATHETERS, UROLOGICAL
FDA 510(k) clearance K944290 · decided 1994-12-08
Clearance details
- K-number
- K944290
- Device name
- CATHETERS, BILIARY CATHETERS, UROLOGICAL
- Applicant
- Boston Scientific Corp
- Decision
- Substantially Equivalent
- Date received
- 1994-09-02
- Decision date
- 1994-12-08
- Days to decision
- 97 days
- Clearance type
- Traditional
- Product code
- FFA
- Device class
- 2
- Regulation number
- 876.5090
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Spencer, IN, US
- Third-party review
- No
- Expedited review
- No
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Devices cleared under the same product code - the starting set for predicate research.
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| SUCTION TUBE (K864770) | New England Surgical Instrument Corp. | 1987-02-24 |
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN DESC recall (Z-1331-2009) | Boston Scientific Corporation | 2009-05-21 |
| Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN DESC recall (Z-1332-2009) | Boston Scientific Corporation | 2009-05-21 |
| Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN DESC recall (Z-1333-2009) | Boston Scientific Corporation | 2009-05-21 |
| Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN# DES recall (Z-1340-2009) | Boston Scientific Corporation | 2009-05-21 |
| Boston Scientific 10 Fr (3.3 mm) Flexima Regular APDL All Purpose Drainage catheter set; R recall (Z-0081-2007) | Boston Scientific Corp | 2006-10-28 |