Cleared Traditional

K903840 - GIANT LUMEN SAFETIP SERIES: ENDOMYOCARDIAL BIOPSY

K903840 is an FDA 510(k) clearance for GIANT LUMEN SAFETIP SERIES: ENDOMYOCARD..., manufactured by Intec Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K903840 · Intec Medical, Inc. · Cardiovascular device
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Oct 1990
Decision
56d
Days
Class 2
Risk

K903840 is an FDA 510(k) clearance for the GIANT LUMEN SAFETIP SERIES: ENDOMYOCARDIAL BIOPSY. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Intec Medical, Inc. (Danvers, US). The FDA issued a Cleared decision on October 16, 1990 after a review of 56 days - a notably fast clearance 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: 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 Intec Medical, Inc. devices

FDA 510(k) Submission Details - K903840

510(k) Number K903840 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 1990
Decision Date October 16, 1990
Days to Decision 56 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
69d faster than avg
Panel avg: 125d · This submission: 56d
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 497
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K903840.
ENTREE SHEATH INTRODUCER SYSTEM
K904475 · Cordis Corp. · Apr 1991
PERCUTANEOUS INTRODUCERS
K903530 · Davol, Inc. · Oct 1990
DATASCOPE PERCOR PERCUTANEOUS INTRODUCER W/PEELABL
K902932 · Datascope Corp. · Oct 1990
PERCUTANEOUS INTRODUCER SET
K902275 · Thomas Medical Products, Inc. · Sep 1990
PERCUTANEOUS CATHETER INTRODUCER KIT
K903906 · Intec Medical, Inc. · Sep 1990
MODELS 6207/6208/6209/6210/6211/6212/6214 (PLI'S)
K900515 · Medtronic Vascular · Aug 1990