Cleared Traditional

K844693 - PEEL-AWAY INTRODUCER SET

K844693 is an FDA 510(k) clearance for PEEL-AWAY INTRODUCER SET, manufactured by Quinton, Inc.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K844693 · Quinton, Inc. · Cardiovascular device
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Mar 1985
Decision
93d
Days
Class 2
Risk

K844693 is an FDA 510(k) clearance for the PEEL-AWAY INTRODUCER SET. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Quinton, Inc. (Seattle, US). The FDA issued a Cleared decision on March 6, 1985 after a review of 93 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1340 - 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 Quinton, Inc. devices

FDA 510(k) Submission Details - K844693

510(k) Number K844693 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 1984
Decision Date March 06, 1985
Days to Decision 93 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 125d · This submission: 93d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DYB Device Classification - Class 2, Special Controls

Product Code DYB Introducer, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1340
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 - DYB Introducer, Catheter

All 620
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K844693.
TELEFLEX MEDICAL INTRODUCER CATHETER
K851141 · Teleflexmedical, Inc. · May 1985
HDC SILCATH SUBCLAVIAN CATHETER PERCUTANEOUS INSER
K851078 · Hdc Corp. · Apr 1985
PERCUTANEOUS CATHETER INTRODUCER W/CATH-SEAL & SID
K850820 · Universal Medical Instrument Corp. · Apr 1985
MEADOX SURGIMED A/S CATHETER SHEATH SYS
K843798 · Meadox Surgimed, Inc. · Dec 1984
MEDTRONIC 6210 PERMANENT LEAD INTRODUC
K842780 · Medtronic Vascular · Aug 1984
PCI W/CATH-SEAL SIDE FLOW FITTING
K842259 · Universal Medical Instrument Corp. · Aug 1984