Cleared Traditional

K921755 - 8 FR SINGLE LUMEN HIGH PERF. GROSHONG CENT. VENOUS

K921755 is an FDA 510(k) clearance for 8 FR SINGLE LUMEN HIGH PERF. GROSHONG C..., manufactured by Davol, Inc.. The device is a Class 2 General Hospital device with product code LJS cleared through the Traditional 510(k) pathway after a 193-day FDA review.

K921755 · Davol, Inc. · General Hospital
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Optimized for regulatory review, auditing and printing
Oct 1992
Decision
193d
Days
Class 2
Risk

K921755 is an FDA 510(k) clearance for the 8 FR SINGLE LUMEN HIGH PERF. GROSHONG CENT. VENOUS. Classified as Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (product code LJS), Class II - Special Controls.

Submitted by Davol, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on October 23, 1992 after a review of 193 days - an extended review 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: 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 Davol, Inc. devices

FDA 510(k) Submission Details - K921755

510(k) Number K921755 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 1992
Decision Date October 23, 1992
Days to Decision 193 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
64d slower than avg
Panel avg: 129d · This submission: 193d
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 256
Devices cleared under the same product code (LJS) and FDA review panel - the closest regulatory comparables to K921755.
INFUSE-A-CATH SILICONE CENTRAL VENOUS CATHETER
K921751 · Strato Medical Corp. · Jul 1993
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 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