PITON(TM) Y-PACK AND PITON(TM) TRI-PACK)— 510(k) K945461
Substantially EquivalentMedtronics Interventional Vascular
FDA 510(k) clearance K945461 for PITON(TM) Y-PACK AND PITON(TM) TRI-PACK), Substantially Equivalent on 1995-02-03. Applicant: Medtronics Interventional Vascular. Device class: 2.
Clearance details
- Applicant
- Medtronics Interventional Vascular
- Product code
- Code DTL
- Device class
- Class 2
- Regulation
- 21 CFR 870.4290
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Danvers, MA, US
Recent devices under product code DTL
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- K972944 — MEDTRONIC MUSTANG SUPER FLOPPY GUIDE WIRE/FLOPPY GUIDE WIRE/INTERMEDIATE GUIDE WIRE/STANDARD GUIDE WIRE/EXTRA SUPPORT
Adverse events under product code DTL
product code DTL- Malfunction
- 770
- Total
- 770
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.