Cleared Traditional

K121694 - IMAGER II ANGIOGRAPHIC CATHETER

K121694 is an FDA 510(k) clearance for IMAGER II ANGIOGRAPHIC CATHETER, manufactured by Boston Scientific Corp. The device is a Class 2 Cardiovascular device with product code DQO cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K121694 · Boston Scientific Corp · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2012
Decision
99d
Days
Class 2
Risk

K121694 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 Corp (Maple Grove, US). The FDA issued a Cleared decision on September 14, 2012 after a review of 99 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. 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 Boston Scientific Corp devices

FDA 510(k) Submission Details - K121694

510(k) Number K121694 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 2012
Decision Date September 14, 2012
Days to Decision 99 days
Submission Type Traditional
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
26d faster than avg
Panel avg: 125d · This submission: 99d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 377
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K121694.
BEACON TIP TORCON NB ADVANTAGE CATHETER, TORCON NB ADVANTAGE CATHETER
K133130 · Cook, Inc. · Jan 2015
MODIFIED CONCENTRIC MICROCATHETER
K131437 · Concentric Medical, Inc. · Oct 2013
SLIP-CATH BEACON TIP CATHETER MODEL SCBR (PRODUCT PREFIX), SHUTTLE SELECT SLIP-CATH CATHETER MODEL SCBR (PRODUCT PREFIX)
K122937 · Cook, Inc. · Dec 2012
MEDLINE HIGH PRESSURE INJECTION TUBING
K120008 · Medline Industries, Inc. · Aug 2012
HEADWAY DUO MICROCATHETER
K120917 · MicroVention, Inc. · Aug 2012
NMI MICROCATHETER
K121954 · Navilyst Medical, Inc. · Jul 2012