CLIRPATH TURBO PLUS EXCIMER LASER CATHETERS, MODELS 314-151, 314-159, 317-152, 317-156, 320-006, 320-159, 323-001— 510(k) K052514

Name: FDA 510(k) clearance K052514
Creator: U.S. Food and Drug Administration
Published: 2005-10-19

Substantially Equivalent

Spectranetics Corp.

FDA 510(k) clearance K052514 for CLIRPATH TURBO PLUS EXCIMER LASER CATHETERS, MODELS 314-151, 314-159, 317-152, 317-156, 320-006, 320-159, 323-001, Substantially Equivalent on 2005-10-19. Applicant: Spectranetics Corp.. Device class: 2.

Clearance details

Applicant: Spectranetics Corp.
Product code: Code PDU
Device class: Class 2
Regulation: 21 CFR 870.1250
Advisory panel: Cardiovascular
Date received: 2005-09-14
Decision date: 2005-10-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Colorado Springs, CO, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code PDU

view all

K262013 — Kiba CTO Crossing Catheter2026-08-28
K252315 — Santreva-ATK Endovascular Revasculariztion Catheter2025-09-22
K251158 — PowerWire® 14 Radiofrequency Guidewire Kit2025-09-11
K251376 — LimFlow ARC2025-05-31
K232562 — PowerWire Radiofrequency Guidewire Kit2024-02-28

More clearances from Spectranetics Corp.

view all

K140047 — LEXICONTURE MECHANICAL DILATOR SHEATH SET2014-04-09
K123632 — 2.5MM TURBO ELITE 035, 2.3MM TURBO ELITE 0352013-01-25
K112032 — 8FR TURBO - TANDEM SYSTEM2011-10-17
K093257 — TORQMAX SHEATH GRIP ACCESSORY2010-03-26
K094036 — TURBO-TANDEM SYSTEM MODEL 472-1102010-01-25

Adverse events under product code PDU

product code PDU

Malfunction: 793
Total: 793

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.