The following data is part of a premarket notification filed by Medi-globe Corp. with the FDA for Stone Extractor Balloon Catheter.
| Device ID | K011261 |
| 510k Number | K011261 |
| Device Name: | STONE EXTRACTOR BALLOON CATHETER |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | MEDI-GLOBE CORP. 6202 SOUTH MAPLE AVE. # 131 Tempe, AZ 85283 |
| Contact | Scott Karler |
| Correspondent | Scott Karler MEDI-GLOBE CORP. 6202 SOUTH MAPLE AVE. # 131 Tempe, AZ 85283 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-25 |
| Decision Date | 2003-11-17 |