Cleared Special

K020028 - 6F MACH1/34356-XXX

Also marketed or referenced as:
5F MACH1/35845-XXX 7F MACH1/34357-XXX 8F MACH1/34358-XXX

K020028 is the FDA 510(k) clearance for 6F MACH1/34356-XXX by Boston Scientific. It is a Class 2 Cardiovascular device (product code DQY) cleared through the Special 510(k) pathway after a 18-day FDA review.

K020028 · Boston Scientific · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2002
Decision
18d
Days
Class 2
Risk

K020028 is an FDA 510(k) clearance for the 6F MACH1/34356-XXX. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Boston Scientific (Maple Grove, US). The FDA issued a Cleared decision on January 22, 2002 after a review of 18 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Boston Scientific devices

Submission Details

510(k) Number K020028 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 2002
Decision Date January 22, 2002
Days to Decision 18 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
107d faster than avg
Panel avg: 125d · This submission: 18d
Pathway characteristics
Modification to existing cleared device.

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 573
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K020028.
10600 DEFLECTABLE CATHETER SYSTEM, MODEL 10600
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K020161 · Guidant Corp. · Feb 2002
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K014212 · C.R. Bard, Inc. · Jan 2002
NUMED MULLINS PTA CATHETER
K013601 · NuMED, Inc. · Jan 2002
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K011889 · Boston Scientific Corp · Dec 2001