Cleared Traditional

K911067 - NORCATH VASCULAR ACCESS CATHETERS

K911067 is an FDA 510(k) clearance for NORCATH VASCULAR ACCESS CATHETERS, manufactured by Norfolk Medical. The device is a Class 2 General Hospital device with product code LJS cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K911067 · Norfolk Medical · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1991
Decision
84d
Days
Class 2
Risk

K911067 is an FDA 510(k) clearance for the NORCATH VASCULAR ACCESS CATHETERS. Classified as Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (product code LJS), Class II - Special Controls.

Submitted by Norfolk Medical (Skokie, US). The FDA issued a Cleared decision on June 3, 1991 after a review of 84 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 Norfolk Medical devices

FDA 510(k) Submission Details - K911067

510(k) Number K911067 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 1991
Decision Date June 03, 1991
Days to Decision 84 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 129d · This submission: 84d
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 252
Devices cleared under the same product code (LJS) and FDA review panel - the closest regulatory comparables to K911067.
L-CATH PEEL AWAY SYSTEM CATHETER
K920755 · Luther Medical Products, Inc. · Jun 1993
NEEDLELESS INJECTION CANNULA
K923653 · Arrow Intl., Inc. · May 1993
8 FR SINGLE LUMEN HIGH PERF. GROSHONG CENT. VENOUS
K921755 · Davol, Inc. · Oct 1992
8 FR SINGLE LUMEN HIGH PERFORMANCE CATHETER
K910486 · Davol, Inc. · Apr 1991
GESCO PER-Q-CATH REPAIR KIT
K910622 · Gesco Intl., Inc. · Mar 1991
VYGON LIFEVAC PICC
K903648 · Vygon Corp. · Mar 1991