EXTRACTOR PRO RX RETRIEVAL BALLONS, EXTRACTOR PRO XL RETRIEVAL BALLONS, EXTRACTOR PRO DL RETRIEVAL BALLONS MODEL M005470
FDA 510(k) clearance K102082 · decided 2010-08-23
Clearance details
- K-number
- K102082
- Device name
- EXTRACTOR PRO RX RETRIEVAL BALLONS, EXTRACTOR PRO XL RETRIEVAL BALLONS, EXTRACTOR PRO DL RETRIEVAL BALLONS MODEL M005470
- Applicant
- Boston Scientific Corp
- Decision
- Substantially Equivalent
- Date received
- 2010-07-26
- Decision date
- 2010-08-23
- Days to decision
- 28 days
- Clearance type
- Special
- Product code
- FGE
- Device class
- 2
- Regulation number
- 876.5010
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Marlboro, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Extractor Pro RX Retrieval Balloon Catheter; UPN (REF): (1) M00547030 (9-12mm Below), (2) recall (Z-2618-2025) | Boston Scientific Corporation | 2025-09-23 |
| Extractor Pro RX Retrieval Balloon Catheter 9-12 mm Above Retrieval Balloon Catheter; Univ recall (Z-1941-2015) | Boston Scientific Corporation | 2015-07-01 |
| Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 9-12 mm Injects Above UPN: M recall (Z-0710-2014) | Boston Scientific Corporation | 2014-01-10 |
| Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 12-15 mm Injects Above UPN: recall (Z-0711-2014) | Boston Scientific Corporation | 2014-01-10 |
| Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 12-15 mm Injects Below UPN : recall (Z-0712-2014) | Boston Scientific Corporation | 2014-01-10 |