Cleared Traditional

K951078 - CATHETER, INTRAVASCULAR OR PERCUTANEOUS

K951078 is an FDA 510(k) clearance for CATHETER, manufactured by Sims Deltec, Inc.. The device is a Class 2 General Hospital device with product code LJS cleared through the Traditional 510(k) pathway after a 144-day FDA review.

K951078 · Sims Deltec, Inc. · General Hospital
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Jul 1995
Decision
144d
Days
Class 2
Risk

K951078 is an FDA 510(k) clearance for the CATHETER, INTRAVASCULAR OR PERCUTANEOUS. Classified as Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (product code LJS), Class II - Special Controls.

Submitted by Sims Deltec, Inc. (St. Paul, US). The FDA issued a Cleared decision on July 31, 1995 after a review of 144 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 Sims Deltec, Inc. devices

FDA 510(k) Submission Details - K951078

510(k) Number K951078 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 1995
Decision Date July 31, 1995
Days to Decision 144 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
15d slower than avg
Panel avg: 129d · This submission: 144d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LJS Device Classification - Class 2, Special Controls

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 266
Devices cleared under the same product code (LJS) and FDA review panel - the closest regulatory comparables to K951078.
PS MEDICAL IPI VASCULAR ACCESS CATHETER
K954409 · Pudenz-Schulte Medical Research Corp. · Dec 1995
PER-Q-CATH MID-LINE
K954422 · Gesco Intl., Inc. · Dec 1995
PER-Q-CATH & PER-Q-CATH DUAL MUMEN CATHETERS, TRAYS & ACCESSORY DEVICES
K954104 · C.R. Bard, Inc. · Nov 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
STRATO MEDICAL INFUSE-A-CATH, TRIPLE LUMEN POLYURETHANE, CENTRAL VNOUS CATHETER SYSTEMS
K946250 · Strato Medical Corp. · May 1995