Cleared Special

K011664 - IMAGER II ANGIOGRAPHIC CATHETER

K011664 is an FDA 510(k) clearance for IMAGER II ANGIOGRAPHIC CATHETER, manufactured by Boston Scientific/Medi-Tech. The device is a Class 2 Cardiovascular device with product code DQO cleared through the Special 510(k) pathway after a 100-day FDA review.

K011664 · Boston Scientific/Medi-Tech · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2001
Decision
100d
Days
Class 2
Risk

K011664 is an FDA 510(k) clearance for the IMAGER II ANGIOGRAPHIC CATHETER. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Boston Scientific/Medi-Tech (Natick,, US). The FDA issued a Cleared decision on September 7, 2001 after a review of 100 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - 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. Standard predicate reliance. 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/Medi-Tech devices

FDA 510(k) Submission Details - K011664

510(k) Number K011664 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 2001
Decision Date September 07, 2001
Days to Decision 100 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
25d faster than avg
Panel avg: 125d · This submission: 100d
Pathway characteristics
Modification to existing cleared device.

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 425
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K011664.
EDWARDS LIFESCIENCES SWAN-GANZ MONITORING CATHETER WITH OLIGON MATERIAL
K014054 · Edwards Lifesciences, LLC · Mar 2002
MODIFICATION TO RENEGADE FIBER BRAIDED MICROCATHETER
K020012 · Boston Scientific/Medi-Tech · Jan 2002
BIOCARDIA UNIVERSAL DEFLECTABLE GUIDE CATHETER, MODEL 000664
K012749 · Biocardia, Inc. · Jan 2002
ORIGEN DUAL LUMEN CATHETER
K003288 · Origen Biomedical, Inc. · Jun 2001
BIOSPHERE MEDICAL INFUSION CATHETER
K003105 · Biosphere Medical · May 2001
CONCENTRIC MICRO CATHETER, MODELS 90001 TO 90008
K003086 · Concentric Medical, Inc. · May 2001