Cleared Traditional

K970207 - MEDI-TECH 5 FRENCH NIGHTHAWK SELECTIVE ...

K970207 is the FDA 510(k) clearance for MEDI-TECH 5 FRENCH NIGHTHAWK SELECTIVE ... by Boston Scientific Corp. It is a Class 2 Cardiovascular device (product code DQO) cleared through the Traditional 510(k) pathway after a 191-day FDA review.

K970207 · Boston Scientific Corp · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1997
Decision
191d
Days
Class 2
Risk

K970207 is an FDA 510(k) clearance for the MEDI-TECH 5 FRENCH NIGHTHAWK SELECTIVE ANGIOGRAPHIC CATHETERS. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Boston Scientific Corp (Maple Grove, US). The FDA issued a Cleared decision on July 31, 1997 after a review of 191 days - an extended review 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: 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 Boston Scientific Corp devices

Submission Details

510(k) Number K970207 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 1997
Decision Date July 31, 1997
Days to Decision 191 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
66d slower than avg
Panel avg: 125d · This submission: 191d
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 289
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K970207.
RETRIEVER II
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K965112 · Medline Industries, Inc. · Oct 1997
5 FR AND 6 FR INFINITI ANGIOGRAPHIC CATHETER
K970854 · Cordis Corp. · Sep 1997
MEDI-TECH 4 AND 5 FRENCH NIGHTHAWK FLUSH ANGIOGRAPHIC CATHETERS
K971607 · Boston Scientific Corp · Jul 1997
4F NYLEX ANGIOGRAPHY CATHETER/5F NYLEX ANGIOGRAPHY CATHETER
K971646 · Cordis Corp. · Jul 1997
USCI MAINSTAY GUIDING CATHETER
K971034 · C.R. Bard, Inc. · May 1997