The following data is part of a premarket notification filed by Aomori Olympus Co., Ltd. with the FDA for Single Use 3-lumen Balloon Catheter, Models B-230q-a And B-230q-b.
| Device ID | K033333 |
| 510k Number | K033333 |
| Device Name: | SINGLE USE 3-LUMEN BALLOON CATHETER, MODELS B-230Q-A AND B-230Q-B |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | AOMORI OLYMPUS CO., LTD. 2 CORPORATE CENTER DR. Melville, NY 11747 -3157 |
| Contact | Tina Steffanie-oak |
| Correspondent | Tina Steffanie-oak AOMORI OLYMPUS CO., LTD. 2 CORPORATE CENTER DR. Melville, NY 11747 -3157 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-10-16 |
| Decision Date | 2003-11-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14953170183451 | K033333 | 000 |
| 14953170183437 | K033333 | 000 |