The following data is part of a premarket notification filed by Boston Scientific Corp. with the FDA for Microvasive Zero Tip Airway Retrieval Basket, Models M00513200 And M00513210.
| Device ID | K020765 |
| 510k Number | K020765 |
| Device Name: | MICROVASIVE ZERO TIP AIRWAY RETRIEVAL BASKET, MODELS M00513200 AND M00513210 |
| Classification | Bronchoscope Accessory |
| Applicant | BOSTON SCIENTIFIC CORP. ONE BOSTON SCIENTIFIC PLACE Natick, MA 01760 -1537 |
| Contact | Paige Sweeney |
| Correspondent | Paige Sweeney BOSTON SCIENTIFIC CORP. ONE BOSTON SCIENTIFIC PLACE Natick, MA 01760 -1537 |
| Product Code | KTI |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-03-08 |
| Decision Date | 2002-04-05 |
| Summary: | summary |