K072230 is an FDA 510(k) clearance for the POWERPICC SOLO. This device is classified as a Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (Class II - Special Controls, product code LJS).
Submitted by C.R. Bard, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on October 5, 2007, 56 days after receiving the submission on August 10, 2007.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5970.
| 510(k) Number | K072230 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 10, 2007 |
| Decision Date | October 05, 2007 |
| Days to Decision | 56 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | LJS — Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5970 |