TightRail Guardian Motorized Dilator Sheath, 9 French (575-009) +2 more— 510(k) K223472
Substantially EquivalentSpectranetics, Inc.
FDA 510(k) clearance K223472 for TightRail Guardian Motorized Dilator Sheath, 9 French (575-009) +2 more, Substantially Equivalent on 2022-12-15. Applicant: Spectranetics, Inc.. Device class: 2.
Clearance details
- Device name as filed
- TightRail Guardian Motorized Dilator Sheath, 9 French (575-009); TightRail Guardian Motorized Dilator Sheath, 11 French (575-011); TightRail Guardian Motorized Dilator Sheath, 13 French (575-013)
- 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- 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
- K180694 — Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters
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.