Cleared Traditional

K946250 - STRATO MEDICAL INFUSE-A-CATH

K946250 is the FDA 510(k) clearance for STRATO MEDICAL INFUSE-A-CATH by Strato Medical Corp.. It is a Class 2 General Hospital device (product code LJS) cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K946250 · Strato Medical Corp. · General Hospital
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May 1995
Decision
130d
Days
Class 2
Risk

K946250 is an FDA 510(k) clearance for the STRATO MEDICAL INFUSE-A-CATH, TRIPLE LUMEN POLYURETHANE, CENTRAL VNOUS CATHET.... 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 May 2, 1995 after a review of 130 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Strato Medical Corp. devices

Submission Details

510(k) Number K946250 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received December 23, 1994
Decision Date May 02, 1995
Days to Decision 130 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
1d slower than avg
Panel avg: 129d · This submission: 130d
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 186
Devices cleared under the same product code (LJS) and FDA review panel - the closest regulatory comparables to K946250.
CATHETER, INTRAVASCULAR OR PERCUTANEOUS
K951078 · Sims Deltec, Inc. · Jul 1995
STRATO MEDICAL INFUSE-A-CATH TRIPLE LUMEN SILICONE CATHETER SYSTEMS
K945956 · Strato Medical Corp. · Jun 1995
HDC VADD (VASCULAR ACCESS DEVICE) TUNNELER
K951098 · Hdc Corp. · Jun 1995
PHARMACIA DELTEC PERIPHERALLY INSERTED VENOUS CATH
K932198 · Pharmacia Deltec, Inc. · May 1994
PROCEDURAL TRAY FOR PERIPHERALLY INSERTED VENOUS
K932211 · Pharmacia Deltec, Inc. · May 1994
DUAL LUMEN PERIPHERALLY INSERTED VENOUS CATHETER
K932430 · Pharmacia Deltec, Inc. · May 1994