Cleared Traditional

K897152 - CRAGG CONVERTIBLE WIRE

K897152 is the FDA 510(k) clearance for CRAGG CONVERTIBLE WIRE by Boston Scientific Corp. It is a Class 2 Cardiovascular device (product code DQX) cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K897152 · Boston Scientific Corp · Cardiovascular device
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Feb 1990
Decision
58d
Days
Class 2
Risk

K897152 is an FDA 510(k) clearance for the CRAGG CONVERTIBLE WIRE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Boston Scientific Corp (Watertown, US). The FDA issued a Cleared decision on February 22, 1990 after a review of 58 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1330 - 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 Boston Scientific Corp devices

Submission Details

510(k) Number K897152 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 1989
Decision Date February 22, 1990
Days to Decision 58 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
67d faster than avg
Panel avg: 125d · This submission: 58d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQX Wire, Guide, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1330
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 - DQX Wire, Guide, Catheter

All 498
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K897152.
DATASCOPE SLIDEWIRE(TM)
K901347 · Datascope Corp. · Jun 1990
ACS ADVANCED CONCEPT GUIDE WIRE
K900386 · Advanced Cardiovascular Systems, Inc. · Jun 1990
INSITE STEERABLE GUIDEWIRE
K901224 · Lake Region Mfg., Inc. · Jun 1990
ACS GOLD SERIES ELASTINITE GUIDE WIRE
K896379 · Advanced Cardiovascular Systems, Inc. · Feb 1990
DATASCOPE STEERING HANDLE
K894940 · Datascope Corp. · Nov 1989
CORDIS STEERABLE COATED GUIDEWIRE
K894633 · Cordis Corp. · Oct 1989