8FR TURBO - TANDEM SYSTEM— 510(k) K112032

Name: FDA 510(k) clearance K112032
Creator: U.S. Food and Drug Administration
Published: 2011-10-17

Substantially Equivalent

Spectranetics Corp.

FDA 510(k) clearance K112032 for 8FR TURBO - TANDEM SYSTEM, Substantially Equivalent on 2011-10-17. Applicant: Spectranetics Corp.. Device class: 2.

Clearance details

Applicant: Spectranetics Corp.
Product code: Code DQY
Device class: Class 2
Regulation: 21 CFR 870.1250
Advisory panel: Cardiovascular
Date received: 2011-07-15
Decision date: 2011-10-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Colorado Springs, CO, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DQY

view all

K260559 — NHanceIT2026-08-14
K262392 — APRO 35 Swift Catheter2026-08-12
K261766 — CPS Locator 3D Plus Delivery Catheter2026-07-29
K262240 — SSPC NXT Delivery Catheter2026-07-29
K261825 — Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP Catheter2026-07-02

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
K093257 — TORQMAX SHEATH GRIP ACCESSORY2010-03-26
K094036 — TURBO-TANDEM SYSTEM MODEL 472-1102010-01-25
K092378 — SPECTRANETICS VISISHEATH DILATOR SHEATH2009-11-02

Adverse events under product code DQY

product code DQY

Death: 464
Injury: 4,489
Malfunction: 13,721
Other: 2
Total: 18,676

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.