Cleared Traditional

K875325 - MODIFIED OCCLUDER/FLUSHING CATHETER STO...

K875325 is the FDA 510(k) clearance for MODIFIED OCCLUDER/FLUSHING CATHETER STO... by Schneider-Shilley (Usa). It is a Class 2 Cardiovascular device (product code DQO) cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K875325 · Schneider-Shilley (Usa) · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1988
Decision
51d
Days
Class 2
Risk

K875325 is an FDA 510(k) clearance for the MODIFIED OCCLUDER/FLUSHING CATHETER STOPCOCK. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Schneider-Shilley (Usa) (Minneapolis, US). The FDA issued a Cleared decision on February 18, 1988 after a review of 51 days - a notably fast clearance 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: 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 Schneider-Shilley (Usa) devices

Submission Details

510(k) Number K875325 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 1987
Decision Date February 18, 1988
Days to Decision 51 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 125d · This submission: 51d
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 292
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K875325.
CATH LAB MONITORING CATHETER
K884065 · C.R. Bard, Inc. · Jan 1989
USCI SOFT-TIP ANGIOGRAPHIC CATHETER
K883051 · C.R. Bard, Inc. · Oct 1988
SLIP-COAT(TM) CATHETERS
K882796 · Cook, Inc. · Jul 1988
TARGET THERAPEUTICS STERILE PRODUCTS
K874815 · Target Therapeutics · Feb 1988
USCI (R) 8F LARGE LUMEN SOFT TIP GUIDE CATHETER
K873438 · C.R. Bard, Inc. · Nov 1987
GUIDING CATHETER
K873004 · Mallinckrodt Critical Care · Sep 1987