Cleared Traditional

K905625 - CVIS INSIGHT IMAGING CATHETER

K905625 is an FDA 510(k) clearance for CVIS INSIGHT IMAGING CATHETER, manufactured by Cardiovascular Imaging Systems, Inc.. The device is a Class 2 Cardiovascular device with product code DQO cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K905625 · Cardiovascular Imaging Systems, Inc. · Cardiovascular device
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Feb 1991
Decision
69d
Days
Class 2
Risk

K905625 is an FDA 510(k) clearance for the CVIS INSIGHT IMAGING CATHETER. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Cardiovascular Imaging Systems, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on February 21, 1991 after a review of 69 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cardiovascular Imaging Systems, Inc. devices

FDA 510(k) Submission Details - K905625

510(k) Number K905625 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 1990
Decision Date February 21, 1991
Days to Decision 69 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 125d · This submission: 69d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQO Device Classification - Class 2, Special Controls

Product Code DQO Catheter, Intravascular, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DQO Catheter, Intravascular, Diagnostic

All 350
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K905625.
BAXTER MARATHON(R) INTRAVASCULAR GUIDING CATHETERS
K910208 · Baxter Healthcare Corp · Apr 1991
DIAGNOSTIC INTRASCULAR CATHETER
K903848 · Applied Vascular Devices, Inc. · Mar 1991
ACS ANGIOSCOPIC CATHETER
K905715 · Advanced Cardiovascular Systems, Inc. · Mar 1991
SCIMD 7 FR. TRIGUIDE GUIDING CATHETER
K905499 · Scimed Life Systems, Inc. · Feb 1991
TMP LEFT ATRIAL PRESSURE CATH CAT.# 100-00X-000
K904491 · Lifestream Int'L, Inc. · Feb 1991
DIAVENTIONAL CATHETER
K905297 · Cordis Corp. · Feb 1991