Cleared Traditional

K963097 - CLAMPLESS VALVED CATHETER-PICC (CVC-PICC)

K963097 is an FDA 510(k) clearance for CLAMPLESS VALVED CATHETER-PICC (CVC-PICC), manufactured by Bmw Medical, Inc.. The device is a Class 2 General Hospital device with product code LJS cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K963097 · Bmw Medical, Inc. · General Hospital
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Oct 1996
Decision
70d
Days
Class 2
Risk

K963097 is an FDA 510(k) clearance for the CLAMPLESS VALVED CATHETER-PICC (CVC-PICC). Classified as Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (product code LJS), Class II - Special Controls.

Submitted by Bmw Medical, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on October 18, 1996 after a review of 70 days - a notably fast clearance cycle.

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: 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 Bmw Medical, Inc. devices

FDA 510(k) Submission Details - K963097

510(k) Number K963097 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 1996
Decision Date October 18, 1996
Days to Decision 70 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
59d faster than avg
Panel avg: 129d · This submission: 70d
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 225
Devices cleared under the same product code (LJS) and FDA review panel - the closest regulatory comparables to K963097.
PERIPHERALLY INSERTED MEDLINE CATHETER
K963257 · Arrow Intl., Inc. · Mar 1997
CLAMPLESS VALVED CATHETER - TUNNELED (CVC-T)
K963806 · Bmw Medical, Inc. · Dec 1996
CLAMPLESS VALVED CATHETER - MIDLINE (CVC-ML)
K963215 · Bmw Medical, Inc. · Nov 1996
CATHETER INSERTION TRAY
K962849 · Medcare Medical Group, Inc. · Oct 1996
MEDTRONIC PS MEDICAL BIOGLIDE VASCULAR CATHETER, SNGL LUMEN MODEL NOS 8960 & 8932
K960055 · Pudenz-Schulte Medical Research Corp. · Sep 1996
CLAMPLESS VALVED CATHETER
K962300 · Bmw Medical, Inc. · Sep 1996