510(k) K050232 ยท PID Esophageal Dilator Balloon With Or Without Electrode Sensors
RIGIFLEX SINGLE-USE ACHALASIA BALLOON DILATOR
| Applicant | Boston Scientific Corp, Natick, MA, US |
| Decision | Substantially Equivalent, Mar 11, 2005 |
| Received | Feb 1, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K050232
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 10, 2013 | Boston Scientific Corporation RigiflexTM 11 Single-Use Achalasia Balloon Dilator, Material Number (UPN) M00554510
Product Usage:
The Boston Scientific Corporation RigiflexTM II Single- Use Achalasia Balloon Dilator is indicated f Terminated |
KNQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.