The following data is part of a premarket notification filed by Olympus Medical Systems Corporation with the FDA for Single Use 3-lumen Extraction Balloon V, Model V B-v233p-a,b-v233p-b,b-v433p-a,b-v433p-b, Bv243q-a, B-v243q-b, B-v443q-a.
| Device ID | K091495 |
| 510k Number | K091495 |
| Device Name: | SINGLE USE 3-LUMEN EXTRACTION BALLOON V, MODEL V B-V233P-A,B-V233P-B,B-V433P-A,B-V433P-B, BV243Q-A, B-V243Q-B, B-V443Q-A |
| Classification | Dislodger, Stone, Biliary |
| Applicant | OLYMPUS MEDICAL SYSTEMS CORPORATION 3500 CORPORATE PARKWAY Center Valley, PA 18034 -0610 |
| Contact | Stacy Abbatiello |
| Correspondent | Stacy Abbatiello OLYMPUS MEDICAL SYSTEMS CORPORATION 3500 CORPORATE PARKWAY Center Valley, PA 18034 -0610 |
| Product Code | LQR |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-05-20 |
| Decision Date | 2009-09-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14953170368773 | K091495 | 000 |
| 14953170275705 | K091495 | 000 |
| 14953170275743 | K091495 | 000 |
| 14953170275767 | K091495 | 000 |
| 14953170279512 | K091495 | 000 |
| 14953170279529 | K091495 | 000 |
| 14953170279550 | K091495 | 000 |
| 14953170279567 | K091495 | 000 |
| 14953170368704 | K091495 | 000 |
| 14953170368711 | K091495 | 000 |
| 14953170368728 | K091495 | 000 |
| 14953170368735 | K091495 | 000 |
| 14953170368742 | K091495 | 000 |
| 14953170368759 | K091495 | 000 |
| 14953170368766 | K091495 | 000 |
| 14953170275699 | K091495 | 000 |