Cleared Special

K062126 - EMBOCATH PLUS INFUSION MICROCATHETER, MODEL ECP-100 AND ECP-135

K062126 is an FDA 510(k) clearance for EMBOCATH PLUS INFUSION MICROCATHETER, manufactured by Biosphere Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DQO cleared through the Special 510(k) pathway after a 14-day FDA review.

K062126 · Biosphere Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2006
Decision
14d
Days
Class 2
Risk

K062126 is an FDA 510(k) clearance for the EMBOCATH PLUS INFUSION MICROCATHETER, MODEL ECP-100 AND ECP-135. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Biosphere Medical, Inc. (Rockland, US). The FDA issued a Cleared decision on August 9, 2006 after a review of 14 days - a notably fast clearance cycle.

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. 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.

FDA 510(k) Submission Details - K062126

510(k) Number K062126 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 2006
Decision Date August 09, 2006
Days to Decision 14 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
111d faster than avg
Panel avg: 125d · This submission: 14d
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 441
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K062126.
INNERCHANGE MICRO-INTRODUCER CATHETER, MODELS 7900 THROUGH 7905
K062627 · Vascular Solutions, Inc. · Jan 2007
MODIFICATION TO ATLANTIS SR PRO 2 AND SR PRO CORONARY IMAGING CATHETERS, MODEL 39014 AND 38942
K063312 · Boston Scientific Corp · Nov 2006
ANGIODYNAMICS SOFT-VU AND MARINER HYDROPHILIC COATED ANGIOGRAPHIC CATHETER
K061733 · AngioDynamics, Inc. · Aug 2006
NAUTIFLUX
K060010 · Sedat · Aug 2006
MICRUS MICROCATHETER COURIER PRE-SHAPED, MODELS MPS170045-00, MPS170090-00, MPS190045-00, MPS190090-00
K061963 · Micrus Endovascular Corporation · Aug 2006
LANGSTON DUAL LUMEN CATHETER
K061565 · Vascular Solutions, Inc. · Aug 2006
K062126 · EMBOCATH PLUS INFUSION MICROCATHETER, MODEL ECP-100 AND ECP-135
Download PDF FDA Summary Biosphere Medical, In…