Cleared Special

K070979 - PULL TAB SQUEEZE FLUSH

K070979 is an FDA 510(k) clearance for PULL TAB SQUEEZE FLUSH, manufactured by Icu Medical, Inc.. The device is a Class 2 Cardiovascular device with product code KRA cleared through the Special 510(k) pathway after a 166-day FDA review.

K070979 · Icu Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2007
Decision
166d
Days
Class 2
Risk

K070979 is an FDA 510(k) clearance for the PULL TAB SQUEEZE FLUSH. Classified as Catheter, Continuous Flush (product code KRA), Class II - Special Controls.

Submitted by Icu Medical, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on September 19, 2007 after a review of 166 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1210 - 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.

FDA 510(k) Submission Details - K070979

510(k) Number K070979 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 2007
Decision Date September 19, 2007
Days to Decision 166 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
41d slower than avg
Panel avg: 125d · This submission: 166d
Pathway characteristics
Modification to existing cleared device.

KRA Device Classification - Class 2, Special Controls

Product Code KRA Catheter, Continuous Flush
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1210
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 - KRA Catheter, Continuous Flush

All 175
Devices cleared under the same product code (KRA) and FDA review panel - the closest regulatory comparables to K070979.
CLARIVEIN CATHETER
K071468 · Vascular Insights, LLC · Mar 2008
VARICATH PERIPHERAL INFUSION CATHETER
K073400 · Veinrx, Inc. · Dec 2007
CXI SUPPORT CATHETER
K072724 · Cook, Inc. · Nov 2007
ARGON CONTINUOUS FLUSH DEVICE
K070384 · Argon Medical Devices, Inc. · Mar 2007
MODIFICATION TO HYPERTRANSIT INFUSION CATHETER
K070279 · Cordis Neurovascular, Inc. · Mar 2007
MERCATOR MICROSYRINGE II INFUSION CATHETER
K062752 · Mercator Medsystems, Inc. · Dec 2006
K070979 · PULL TAB SQUEEZE FLUSH
Download PDF FDA Summary Icu Medical, Inc.