TightRail Rotating Dilator Sheath, TightRail Mini Rotating Dilator Sheath— 510(k) K150360
Substantially EquivalentSpectranetics, Inc.
FDA 510(k) clearance K150360 for TightRail Rotating Dilator Sheath, TightRail Mini Rotating Dilator Sheath, Substantially Equivalent on 2015-03-04. Applicant: Spectranetics, Inc.. Device class: 2.
Clearance details
- Applicant
- Spectranetics, Inc.
- Product code
- Code DRE
- Device class
- Class 2
- Regulation
- 21 CFR 870.1310
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Colorado Springs, CO, US
Recent devices under product code DRE
view allMore clearances from Spectranetics, Inc.
view all- K223472 — TightRail Guardian Motorized Dilator Sheath, 9 French (575-009) +2 more
- K222837 — Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters
- K212784 — TightRail Guardian Motorized Dilator Sheath
- DEN210024 — CavaClear Laser Sheath
- K203540 — Bridge Occlusion Balloon
Adverse events under product code DRE
product code DRE- Death
- 100
- Injury
- 832
- Malfunction
- 597
- Other
- 3
- Total
- 1,532
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.