K022059 is an FDA 510(k) clearance for the MICROVASIVE PULMONARY GUIDEWIRE. This device is classified as a Instrument, Manual, Surgical, General Use (Class I - General Controls, product code MDM).
Submitted by Boston Scientific Corp (Natick,, US). The FDA issued a Cleared decision on November 13, 2002, 141 days after receiving the submission on June 25, 2002.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K022059 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 25, 2002 |
| Decision Date | November 13, 2002 |
| Days to Decision | 141 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | MDM — Instrument, Manual, Surgical, General Use |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |