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 |