Cleared Traditional

K895812 - SHARGHP INTRAVENOUS CATHETER

K895812 is an FDA 510(k) clearance for SHARGHP INTRAVENOUS CATHETER, manufactured by Shargh Pharmaceutical Co., Inc.. The device is a Class 2 General Hospital device with product code FOZ cleared through the Traditional 510(k) pathway after a 343-day FDA review.

K895812 · Shargh Pharmaceutical Co., Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1990
Decision
343d
Days
Class 2
Risk

K895812 is an FDA 510(k) clearance for the SHARGHP INTRAVENOUS CATHETER. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Shargh Pharmaceutical Co., Inc. (Culver City, US). The FDA issued a Cleared decision on September 7, 1990 after a review of 343 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5200 - 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. Elevated predicate reliance profile. 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 Shargh Pharmaceutical Co., Inc. devices

FDA 510(k) Submission Details - K895812

510(k) Number K895812 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 1989
Decision Date September 07, 1990
Days to Decision 343 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
214d slower than avg
Panel avg: 129d · This submission: 343d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FOZ Device Classification - Class 2, Special Controls

Product Code FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5200
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 - FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

All 279
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K895812.
KENDALL SAFETRAK(TM) HIGH FLOW CATHETER
K903732 · Kendall Healthcare Products Co. Div.Of Tyco Health · Oct 1990
VAS-CATH TRIFUSION TRIPLE LUMEN INFUSION CATHETER
K895597 · Vas-Cath, Inc. · Sep 1990
SPLIT-SECOND INTRODUCER
K902527 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1990
CATHETER WITH GUIDEWIRE ASSEMBLY DEVICE
K900056 · Abbott Laboratories · Aug 1990
MULTICATH PLACEMENT KIT
K901640 · Vygon Corp. · Aug 1990
ANTIMICROBIAL MULTI-LUMEN CENTRAL VENOUS CATHETER
K900263 · Arrow Intl., Inc. · Jul 1990