FlexCath Select Steerable Shealth and Dilator— 510(k) K163268
Substantially EquivalentMedtronic Cryocath, LP
FDA 510(k) clearance K163268 for FlexCath Select Steerable Shealth and Dilator, Substantially Equivalent on 2017-02-02. Applicant: Medtronic Cryocath, LP. Device class: 2.
Clearance details
- Applicant
- Medtronic Cryocath, LP
- 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
- Mounds View, MN, US
Recent devices under product code DYB
view allMore clearances from Medtronic Cryocath, LP
view all- K202620 — FlexCath Advance Steerable Sheath and Dilator
- K183174 — FlexCath Advance Steerable Sheath and Dilator
- K142684 — FlexCath Select Steerable Sheath (10 French)
- K123591 — FLEXCATH ADVANCE STEERABLE SHEATH (12 FRENCH)
- K102176 — FLEXCATH STEERABLE SHEATH (12 FRENCH), FLEXCATH STEERABLE SHEATH (10 FRENCH) MODEL 3FC12, 3FC10
Adverse 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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.