510(k) K946358 ยท LQR Dislodger, Stone, Biliary
ENDOSCOPIC BILIARY CATHETER
| Applicant | Boston Scientific Corp, Natick, MA, US |
| Decision | Substantially Equivalent, Apr 11, 1995 |
| Received | Dec 30, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K946358
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 11, 2009 | Boston Scientific Corp Boston Scientific Stonetome Stone Removal Device. Triple Lumen Sphincterotome, 5.5 Fr, 20 mm, 11.5 mm, sterile, Boston Scientific Corp., Natick, MA; REF 3511.
The device is used in diagnostic or t Terminated |
LQR | None listed |
| Mar 11, 2009 | Boston Scientific Corp Boston Scientific Stonetome Stone Removal Device. Triple Lumen Sphincterotome, 5.5 Fr, 30 mm, 11.5 mm, sterile, Boston Scientific Corp., Natick, MA; REF 3513.
The device is used in diagnostic or th Terminated |
LQR | None listed |
| Mar 11, 2009 | Boston Scientific Corp Boston Scientific Stonetome Stone Removal Device. Triple Lumen Sphincterotome, 11.5 mm, 5.5 Fr, 20 mm, sterile, Boston Scientific Corp., Natick, MA; REF 3515.
The device is used in diagnostic or th Terminated |
LQR | None listed |
| Jun 27, 2006 | Boston Scientific Corp Boston Scientific Stonetome Stone Removal Device, 20 mm tip, 20 mm cut wire, distal balloon, sterile, single use only, material number M00535110; catalog number 3511. Terminated |
LQR | None listed |
| Jun 27, 2006 | Boston Scientific Corp Boston Scientific Stonetome Stone Removal Device, 20 mm tip, 30 mm cut wire, distal balloon, sterile, single use only, material number M00535130; catalog number 3513. Terminated |
LQR | None listed |
| Jun 27, 2006 | Boston Scientific Corp Boston Scientific Stonetome Stone Removal Device, 5 mm tip, 20 mm cut wire, proximal balloon, sterile, single use only, material number M00535150; catalog number 3515. Terminated |
LQR | None listed |
| Jun 27, 2006 | Boston Scientific Corp Boston Scientific Stonetome Stone Removal Device, 20 mm tip, 20 mm cut wire, proximal balloon, sterile, single use only, material number M00535170; catalog number 3517. Terminated |
LQR | None listed |
| Jun 27, 2006 | Boston Scientific Corp Boston Scientific Stonetome Stone Removal Device, 5 mm tip, 30 mm cut wire, proximal balloon, sterile, single use only, material number M00535190; catalog number 3519. Terminated |
LQR | None listed |
| Jun 27, 2006 | Boston Scientific Corp Boston Scientific Stonetome Stone Removal Device, 20 mm tip, 30 mm cut wire, proximal balloon, sterile, single use only, material number M00535210; catalog number 3521. Terminated |
LQR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.