Cleared Traditional

K845037 - PERCUTANEOUS ANGIOGRAPHIC NEEDLES

K845037 is the FDA 510(k) clearance for PERCUTANEOUS ANGIOGRAPHIC NEEDLES by Mallinckrodt Critical Care. It is a Class 2 Cardiovascular device (product code DYB) cleared through the Traditional 510(k) pathway after a 176-day FDA review.

K845037 · Mallinckrodt Critical Care · Cardiovascular device
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Jun 1985
Decision
176d
Days
Class 2
Risk

K845037 is an FDA 510(k) clearance for the PERCUTANEOUS ANGIOGRAPHIC NEEDLES. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Mallinckrodt Critical Care (St Louis, US). The FDA issued a Cleared decision on June 21, 1985 after a review of 176 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 Mallinckrodt Critical Care devices

Submission Details

510(k) Number K845037 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1984
Decision Date June 21, 1985
Days to Decision 176 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
51d slower than avg
Panel avg: 125d · This submission: 176d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 405
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K845037.
SLIM VENT BIPO PACING LEAD USING A90 INSUL,#30-284
K852916 · Telectronics, Inc. · Jul 1985
SLIM ART/J-SVC IND PACING LEAD USING POLY #30-283
K852917 · Telectronics, Inc. · Jul 1985
SLIM ART J. BIP PACING LEAD USING POLY #030-2821
K852918 · Telectronics, Inc. · Jul 1985
DESERET INTRODUCER SET
K844840 · Parke-Davis Co. · May 1985
TELEFLEX MEDICAL INTRODUCER CATHETER
K851141 · Teleflexmedical, Inc. · May 1985
HDC SILCATH SUBCLAVIAN CATHETER PERCUTANEOUS INSER
K851078 · Hdc Corp. · Apr 1985