PERIPHERAL ATHERECTOMY SYSTEM— 510(k) K890515

Name: FDA 510(k) clearance K890515
Creator: U.S. Food and Drug Administration
Published: 1989-05-23

Substantially Equivalent

Intensive Technology, Inc.

FDA 510(k) clearance K890515 for PERIPHERAL ATHERECTOMY SYSTEM, Substantially Equivalent on 1989-05-23. Applicant: Intensive Technology, Inc.. Device class: 2.

Clearance details

Applicant: Intensive Technology, Inc.
Product code: Code DWX
Device class: Class 2
Regulation: 21 CFR 870.4875
Advisory panel: Cardiovascular
Date received: 1989-02-01
Decision date: 1989-05-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DWX

view all

K121415 — MOLLRING MULTITASC2012-09-05
K032105 — ENDOHELIX ENDARTERECTOMY DEVICE2003-10-30
K020925 — CARBODISSECTING ENDOSCOPE2003-04-29
K003719 — VASCULAR ARCHITECTS PERISCOPE DEVICE2001-02-28
K950813 — MOLLRING CUTTER1995-07-25

More clearances from Intensive Technology, Inc.

view all

K922970 — INTRA-OPERATIVE TEC ATHERECTOMY SYSTEM1993-01-13
K912664 — TEC ROTATING DUAL HEMOVALVE1992-08-24
K911869 — IVT GUIDING CATHETER1991-10-16
K903463 — IVT INTRODUCER SHEATH1991-01-03
K904003 — HEMOCHRON(R) HEPARIN RESPONSE TEST1990-11-29

Data sourced from openFDA. This site is unofficial and independent of the FDA.