Cleared Traditional

INFUSE-A-CATH SILICONE CENTRAL VENOUS CATHETER (K921751) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K921751 · Strato Medical Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1993
Decision
450d
Days
Class 2
Risk

K921751 is an FDA 510(k) clearance for the INFUSE-A-CATH SILICONE CENTRAL VENOUS CATHETER. Classified as Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (product code LJS), Class II - Special Controls.

Submitted by Strato Medical Corp. (Beverly, US). The FDA issued a Cleared decision on July 7, 1993 after a review of 450 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5970 - the FDA general hospital device 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 General Hospital submissions.

View all Strato Medical Corp. devices

Submission Details

510(k) Number K921751 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received April 13, 1992
Decision Date July 07, 1993
Days to Decision 450 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
321d slower than avg
Panel avg: 129d · This submission: 450d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LJS Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5970
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 General Hospital devices follow this clearance model.

Regulatory Peers - LJS Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days

All 79
Devices cleared under the same product code (LJS) and FDA review panel - the closest regulatory comparables to K921751.
POLY PER-Q-CATH PICC CATHETER,MODEL 3236100 AND POLY PER-Q-CATH MIDLINE CATHETER, MODEL 3134135
K001901 · C.R. Bard, Inc. · Sep 2000
AUTO SUTURE CHEMOSITE TUNNELER
K961856 · United States Surgical, A Division of Tyco Healthc · Jul 1996
PER-Q-CATH & PER-Q-CATH DUAL MUMEN CATHETERS, TRAYS & ACCESSORY DEVICES
K954104 · C.R. Bard, Inc. · Nov 1995
DESERET(R) INTRODUCER SET WITH VITACUFF(R) DEVICE
K893126 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1989
MULTILUMEN CENTRAL VENOUS CATH. W/VITACUFF DEVICE
K882448 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1988
GRECO-HARVEY SURFACT BOND CATH HYPERALIMENTATION
K851243 · Cook, Inc. · Mar 1986