Cleared Traditional

K870419 - IVR-SP CUSTOM ANGIOGRAPHY TRAY

K870419 is an FDA 510(k) clearance for IVR-SP CUSTOM ANGIOGRAPHY TRAY, manufactured by North Coast Medi-Tek. The device is a Class 2 Cardiovascular device with product code DQO cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K870419 · North Coast Medi-Tek · Cardiovascular device
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May 1987
Decision
97d
Days
Class 2
Risk

K870419 is an FDA 510(k) clearance for the IVR-SP CUSTOM ANGIOGRAPHY TRAY. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by North Coast Medi-Tek (Mentor, US). The FDA issued a Cleared decision on May 11, 1987 after a review of 97 days - within the typical 510(k) review window.

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: 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 North Coast Medi-Tek devices

FDA 510(k) Submission Details - K870419

510(k) Number K870419 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 1987
Decision Date May 11, 1987
Days to Decision 97 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 125d · This submission: 97d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQO Device Classification - Class 2, Special Controls

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 421
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K870419.
USCI (R) 8F LARGE LUMEN SOFT TIP GUIDE CATHETER
K873438 · C.R. Bard, Inc. · Nov 1987
GUIDING CATHETER
K873004 · Mallinckrodt Critical Care · Sep 1987
DOUBLE LUMEN CATHETER
K872248 · Cordis Corp. · Aug 1987
NUMED BALLOON WEDGE PRESSURE CATHETER
K864943 · NuMED, Inc. · Feb 1987
NUMED BALLOON ANGIOGRAPHIC CATHETERS
K864940 · NuMED, Inc. · Feb 1987
CORDIS CONTRAST INJECTION LINES
K864141 · Cordis Corp. · Nov 1986