PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH— 510(k) K091329
Substantially EquivalentTerumo Medical Corp.
FDA 510(k) clearance K091329 for PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH, Substantially Equivalent on 2009-05-29. Applicant: Terumo Medical Corp.. Device class: 2.
Clearance details
- Applicant
- Terumo Medical Corp.
- Product code
- Code DYB
- Device class
- Class 2
- Regulation
- 21 CFR 870.1340
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Elkton, MD, US
Recent devices under product code DYB
view allMore clearances from Terumo Medical Corp.
view allAdverse events under product code DYB
product code DYB- Death
- 808
- Injury
- 5,922
- Malfunction
- 16,516
- Other
- 5
- Total
- 23,251
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 →
Recalls naming K091329
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K091329.
Data sourced from openFDA. This site is unofficial and independent of the FDA.