Spectranetics Turbo-Elite Laser Atherectomy Catheters— 510(k) K170059
Substantially EquivalentSpectranetics, Inc.
FDA 510(k) clearance K170059 for Spectranetics Turbo-Elite Laser Atherectomy Catheters, Substantially Equivalent on 2017-04-07. Applicant: Spectranetics, Inc.. Device class: 2.
Clearance details
- Applicant
- Spectranetics, Inc.
- Product code
- Code MCW
- Device class
- Class 2
- Regulation
- 21 CFR 870.4875
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Colorado Springs, CO, US
Recent devices under product code MCW
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 MCW
product code MCW- Death
- 38
- Injury
- 1,386
- Malfunction
- 2,676
- Other
- 2
- Total
- 4,102
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 K170059
K-number listed on FDA's recall record- Z-0680-2025 — Turbo Elite Laser Atherectomy Catheter Model Number / UDI-DI code / Product Description 414-151 / 989930000531 / 1.4 mm OTW 417-152 / 989930000551 / 1.7 mm OTW 420-006 / 989930000571 / 2.0 mm OTW 423-001 / 989930000591 / 2.3 mm OTW 425-011 / 989930000601 / 2.5 mm OTW 423-135-01 / 989930004171 / 2.3 mm OTW 423-135-02 / 989930004181 / 2.3 mm OTW 425-135-01 / 989930004201 / 2.5 mm OTW 425-135-02 / 989930004211 / 2.5 mm OTW The Turbo-Elite devices are indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions in humans.
- Z-0509-2024 — Spectranetics Turbo-Elite Laser Atherectomy Catheter 2.0 RX REF 420-159 Spectranetics Turbo-Elite Laser Atherectomy Catheter 2.0 OTW REF 420-006 Spectranetics Turbo-Elite Laser Atherectomy Catheter 1.4 RX REF 414-159 Spectranetics Turbo-Elite Laser Atherectomy Catheter 1.7 OTW REF 417-152 The Turbo-Elite devices are indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions in humans.
- Z-2863-2017 — Spectranetics Turbo-Elite Laser Atherectomy Catheter Peripheral Rapid Exchange Catheters Device is indicated for use in the treatment, including atherectomy, of infrainguinal stenosis and occlusions
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K170059.
Data sourced from openFDA. This site is unofficial and independent of the FDA.