CREGANNA-TACTX STEERABLE SHEATH SET SYMMETRIC— 510(k) K131079
Substantially EquivalentCreganna Medical Devices
FDA 510(k) clearance K131079 for CREGANNA-TACTX STEERABLE SHEATH SET SYMMETRIC, Substantially Equivalent on 2013-08-01. Applicant: Creganna Medical Devices. Device class: 2.
Clearance details
- Applicant
- Creganna Medical Devices
- 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
- Traditional
- Location
- Northborough, MA, US
Recent devices under product code DYB
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 K131079
K-number listed on FDA's recall record- Z-2529-2017 — Boston Scientific Zurpaz(TM) MEDIUM CURL, ASYMMETRIC CURVE, Steerable Sheath, 8.5F (2.83mm), REF Catalog No M004USTMCA85200
- Z-2530-2017 — Boston Scientific Zurpaz(TM) MEDIUM CURL, SYMMETRIC CURVE, Steerable Sheath, 8.5F (2.83mm), REF Catalog No M004USMC85100
- Z-2531-2017 — Boston Scientific Zurpaz(TM) MEDIUM CURL, ASYMMETRIC CURVE, Steerable Sheath, 8.5F (2.83mm), REF Catalog No M004EPTMCA85400
- Z-2532-2017 — Boston Scientific Zurpaz(TM) MEDIUM CURL, ASYMMETRIC CURVE, Steerable Sheath, 8.5F (2.83mm), REF Catalog No M004EPTMCA85300
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K131079.
Data sourced from openFDA. This site is unofficial and independent of the FDA.