Cleared Traditional

K961780 - HEMODIALYSIS INTRODUCER SET

K961780 is an FDA 510(k) clearance for HEMODIALYSIS INTRODUCER SET, manufactured by Thomas Medical Products, Inc.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 230-day FDA review.

K961780 · Thomas Medical Products, Inc. · Cardiovascular device
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Dec 1996
Decision
230d
Days
Class 2
Risk

K961780 is an FDA 510(k) clearance for the HEMODIALYSIS INTRODUCER SET. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Thomas Medical Products, Inc. (Malvern, US). The FDA issued a Cleared decision on December 24, 1996 after a review of 230 days - an extended review cycle.

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 Thomas Medical Products, Inc. devices

FDA 510(k) Submission Details - K961780

510(k) Number K961780 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 1996
Decision Date December 24, 1996
Days to Decision 230 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
105d slower than avg
Panel avg: 125d · This submission: 230d
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 535
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K961780.
EVS
K963886 · Applied Medical Resources · Apr 1997
GSI CANNULA WITH INTRODUCER
K970201 · General Surgical Innovations · Apr 1997
CCENTERMARK CATHETER INTRODUCER SHEALTH WITH PROTECTIV 2000 NEEDLE SAFETY SYSTEM
K962978 · Johnson & Johnson Medical, Inc. · Jan 1997
CATH SEAL
K962180 · Universal Medical Instrument Corp. · Nov 1996
CORDIS AVANTI TRANS-RADIAL CATHETER SHEATH INTRODUCER KIT
K962746 · Cordis Corp. · Oct 1996
BRAUN PERCUTANEOUS INTRODUCER SET
K961745 · B.Braun Medical, Inc. · Sep 1996