Cleared Traditional

K831189 - ANGIOGRAPHIC NEEDLE

K831189 is the FDA 510(k) clearance for ANGIOGRAPHIC NEEDLE by Medrad, Inc.. It is a Class 2 Cardiovascular device (product code DQO) cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K831189 · Medrad, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1983
Decision
27d
Days
Class 2
Risk

K831189 is an FDA 510(k) clearance for the ANGIOGRAPHIC NEEDLE. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Medrad, Inc. (Walker, US). The FDA issued a Cleared decision on May 9, 1983 after a review of 27 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medrad, Inc. devices

Submission Details

510(k) Number K831189 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 1983
Decision Date May 09, 1983
Days to Decision 27 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
98d faster than avg
Panel avg: 125d · This submission: 27d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 294
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K831189.
PERCLUDER DL OCCLUDING BALLOON
K832386 · Datascope Corp. · Oct 1983
COMPRESSAR DISPOSABLE DISC
K831337 · Instromedix, Inc. · Jul 1983
ANGIOGRAPHY KIT W/ADDIT. COMPONENTS
K831509 · Mallinckrodt Critical Care · Jun 1983
CENTRAL VEIN CATHERIZATION KIT-14-690-
K830788 · Norton Performance Plastics Corp. · Apr 1983
DIAGNOSTIC INTRAVASCULAR CATHETER
K830415 · Mallinckrodt Critical Care · Apr 1983
FORGARTY BALLOON CALIBRATOR
K830734 · American Edwards Laboratories · Apr 1983