TightRail Sub-C Rotating Dilator Sheath— 510(k) K161333
Substantially EquivalentSpectranetics, Inc.
FDA 510(k) clearance K161333 for TightRail Sub-C Rotating Dilator Sheath, Substantially Equivalent on 2016-07-08. 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
- Traditional
- 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.