Cleared Traditional

K935292 - SCHNEIDER GUIDEZILLA SOFTIP GUIDING CAT...

K935292 is the FDA 510(k) clearance for SCHNEIDER GUIDEZILLA SOFTIP GUIDING CAT... by Boston Scientific Scimed, Inc.. It is a Class 2 Cardiovascular device (product code DQY) cleared through the Traditional 510(k) pathway after a 220-day FDA review.

K935292 · Boston Scientific Scimed, Inc. · Cardiovascular device
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Jun 1994
Decision
220d
Days
Class 2
Risk

K935292 is an FDA 510(k) clearance for the SCHNEIDER GUIDEZILLA SOFTIP GUIDING CATHETER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Boston Scientific Scimed, Inc. (Plymouth, US). The FDA issued a Cleared decision on June 10, 1994 after a review of 220 days - an extended review cycle.

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: 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 Scimed, Inc. devices

Submission Details

510(k) Number K935292 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 1993
Decision Date June 10, 1994
Days to Decision 220 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
95d slower than avg
Panel avg: 125d · This submission: 220d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 577
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