The following data is part of a premarket notification filed by Boston Scientific Corp. with the FDA for Microvasive Pulmonary Guidewire.
| Device ID | K022059 |
| 510k Number | K022059 |
| Device Name: | MICROVASIVE PULMONARY GUIDEWIRE |
| Classification | Instrument, Manual, Surgical, General Use |
| Applicant | BOSTON SCIENTIFIC CORP. ONE BOSTON SCIENTIFIC PLACE Natick, MA 01760 -1537 |
| Contact | James D Mcmahon |
| Correspondent | James D Mcmahon BOSTON SCIENTIFIC CORP. ONE BOSTON SCIENTIFIC PLACE Natick, MA 01760 -1537 |
| Product Code | MDM |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-25 |
| Decision Date | 2002-11-13 |
| Summary: | summary |