Cleared Traditional

K974683 - NAVIPORT DEFLECTABLE TIP GUIDING CATHETER

K974683 is an FDA 510(k) clearance for NAVIPORT DEFLECTABLE TIP GUIDING CATHETER, manufactured by Cardima, Inc.. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 553-day FDA review.

K974683 · Cardima, Inc. · Cardiovascular device
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Jun 1999
Decision
553d
Days
Class 2
Risk

K974683 is an FDA 510(k) clearance for the NAVIPORT DEFLECTABLE TIP GUIDING CATHETER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Cardima, Inc. (Fremont, US). The FDA issued a Cleared decision on June 22, 1999 after a review of 553 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Cardima, Inc. devices

FDA 510(k) Submission Details - K974683

510(k) Number K974683 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 1997
Decision Date June 22, 1999
Days to Decision 553 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
428d slower than avg
Panel avg: 125d · This submission: 553d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQY Device Classification - Class 2, Special Controls

Product Code DQY Catheter, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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 - DQY Catheter, Percutaneous

All 668
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K974683.
VERIPATH PERIPHERAL GUIDING CATHETER
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K991059 · Spectranetics Corp. · Nov 1999
VISTA BRITE TIP CATHETERS
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ITI INTRAMAX GUIDE CATHETER 91, 78 AND 65
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K990726 · Cook, Inc. · Apr 1999
MEDTRONIC 5F & 9F ZUMA GUIDING CATHETERS
K990707 · Medtronics Interventional Vascular · Mar 1999