Cleared Traditional

K932801 - CARDIMA SEEKER AND STUBBIE GUIDEWIRES

K932801 is an FDA 510(k) clearance for CARDIMA SEEKER AND STUBBIE GUIDEWIRES, manufactured by Cardima, Inc.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K932801 · Cardima, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1993
Decision
84d
Days
Class 2
Risk

K932801 is an FDA 510(k) clearance for the CARDIMA SEEKER AND STUBBIE GUIDEWIRES. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Cardima, Inc. (Fremont, US). The FDA issued a Cleared decision on September 1, 1993 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1330 - 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 Cardima, Inc. devices

FDA 510(k) Submission Details - K932801

510(k) Number K932801 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 1993
Decision Date September 01, 1993
Days to Decision 84 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 125d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQX Device Classification - Class 2, Special Controls

Product Code DQX Wire, Guide, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1330
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 - DQX Wire, Guide, Catheter

All 627
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K932801.
LOC GUIDE WIRE EXTENSION
K934339 · Advanced Cardiovascular Systems, Inc. · Dec 1993
AUTOMATIC PULL BACK DEVICE
K933517 · Cardiovascular Imaging Systems, Inc. · Oct 1993
USCI MACH 10 GUIDE WIRE WITH PRO/PEL COATING
K933466 · C.R. Bard, Inc. · Oct 1993
B-D ARTERIAL BLOOD CONTAINMENT DEVICE
K925947 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1993
ARROW BLOOD CONTAINMENT DEVICE
K924558 · Arrow Intl., Inc. · Aug 1993
NEW HYDROPHILIC COATING FOR WIRE GUIDES
K924385 · Arrow Intl., Inc. · Aug 1993