Submission Details
| 510(k) Number | K101777 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 25, 2010 |
| Decision Date | July 23, 2010 |
| Days to Decision | 28 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Special
PIONEER PLUS CATHETER, MODEL PLUS 120
Jul 2010
Decision
28d
Days
Class 2
Risk
About This 510(k) Submission
K101777 is an FDA 510(k) clearance for the PIONEER PLUS CATHETER, MODEL PLUS 120, a Catheter For Crossing Total Occlusions (Class II — Special Controls, product code PDU), submitted by Medtronic Vascular (Santa Rosa, US). The FDA issued a Cleared decision on July 23, 2010, 28 days after receiving the submission on June 25, 2010. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.
Device Classification
| Product Code | PDU — Catheter For Crossing Total Occlusions |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.1250 |
| Definition | To Facilitate The Intraluminal Placement Of Conventional Guidewires Beyond Stenotic Lesions (including Subchronic And Chronic Total Occlusions) In The Peripheral Vasculature Prior To Further Percutaneous Intervention, Such As Angioplasty, Atherectomy Or Stent Placement. |
Manufacturer
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