Cleared Traditional

K001856 - SUPERCROSS CATHETER

K001856 is the FDA 510(k) clearance for SUPERCROSS CATHETER by Abbott Vascular, Inc.. It is a Class 2 Cardiovascular device (product code DQY) cleared through the Traditional 510(k) pathway after a 261-day FDA review.

K001856 · Abbott Vascular, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2001
Decision
261d
Days
Class 2
Risk

K001856 is an FDA 510(k) clearance for the SUPERCROSS CATHETER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Abbott Vascular, Inc. (Redwood, US). The FDA issued a Cleared decision on March 7, 2001 after a review of 261 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Abbott Vascular, Inc. devices

Submission Details

510(k) Number K001856 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 2000
Decision Date March 07, 2001
Days to Decision 261 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
136d slower than avg
Panel avg: 125d · This submission: 261d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQY Catheter, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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 - DQY Catheter, Percutaneous

All 575
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K001856.
CONCENTRIC RETRIEVER, MODEL 90030
K003410 · Concentric Medical, Inc. · May 2001
CONCENTROC HD GUIDE CATHETER, MODELS 90017 (4F), 90019 (5F), 90021 (6F), 90022 (7F), 90023 (8F), 90024 (9F)
K003880 · Concentric Medical, Inc. · May 2001
NUMED HIGH PRESSURE PTA CATHETERS
K010880 · NuMED, Inc. · Apr 2001
CONCENTRIC GUIDE CATHETER, MODELS 90018, 90020
K003085 · Concentric Medical, Inc. · Mar 2001
BARD UTRAVERSE SMALL VESSEL PTA BALLOON DILATATION CATHETER
K010169 · C.R. Bard, Inc. · Feb 2001
NUMED Z-MED PTV CATHERERS
K003643 · NuMED, Inc. · Dec 2000