Cleared Abbreviated

K003362 - ASTRONOMER+WITH SLD

K003362 is the FDA 510(k) clearance for ASTRONOMER+WITH SLD by Boston Scientific Corp. It is a Class 2 Cardiovascular device (product code DQK) cleared through the Abbreviated 510(k) pathway after a 125-day FDA review.

K003362 · Boston Scientific Corp · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2001
Decision
125d
Days
Class 2
Risk

K003362 is an FDA 510(k) clearance for the ASTRONOMER+WITH SLD. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Boston Scientific Corp (San Jose, US). The FDA issued a Cleared decision on March 1, 2001 after a review of 125 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1425 - the FDA cardiovascular device oversight framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Boston Scientific Corp devices

Submission Details

510(k) Number K003362 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 2000
Decision Date March 01, 2001
Days to Decision 125 days
Submission Type Abbreviated
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
At panel average
Panel avg: 125d · This submission: 125d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code DQK Computer, Diagnostic, Programmable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1425
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 - DQK Computer, Diagnostic, Programmable

All 246
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K003362.
QUINTON Q-CATH, MODEL 000460
K021906 · Quinton, Inc. · Sep 2002
CARTO XP EP NAVIGATION SYSTEM
K013083 · Biosense Webster, Inc. · Nov 2001
SYNETEC
K002817 · Ela Medical, Inc. · May 2001
CATHCOR DESKTOP
K002137 · Siemens Elema AB · Oct 2000
MODIFICATION TO CARTO EP NAVIGATION SYSTEM
K000190 · Biosense Webster, Inc. · May 2000
CARTO EP NAVIGATION SYSTEM
K000248 · Biosense Webster, Inc. · May 2000