Cleared Traditional

K863819 - CHEMO-CATH INTRAPERITONEAL CATHETER

K863819 is an FDA 510(k) clearance for CHEMO-CATH INTRAPERITONEAL CATHETER, manufactured by Hdc Corp.. The device is a Class 2 Gastroenterology & Urology device with product code FJS cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K863819 · Hdc Corp. · Gastroenterology & Urology device
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Feb 1987
Decision
127d
Days
Class 2
Risk

K863819 is an FDA 510(k) clearance for the CHEMO-CATH INTRAPERITONEAL CATHETER. Classified as Catheter, Peritoneal, Long-term Indwelling (product code FJS), Class II - Special Controls.

Submitted by Hdc Corp. (Mountain View, US). The FDA issued a Cleared decision on February 4, 1987 after a review of 127 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5630 - the FDA gastroenterology and urology 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 Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Hdc Corp. devices

FDA 510(k) Submission Details - K863819

510(k) Number K863819 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 1986
Decision Date February 04, 1987
Days to Decision 127 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
3d faster than avg
Panel avg: 130d · This submission: 127d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FJS Device Classification - Class 2, Special Controls

Product Code FJS Catheter, Peritoneal, Long-term Indwelling
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5630
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FJS Catheter, Peritoneal, Long-term Indwelling

All 18
Devices cleared under the same product code (FJS) and FDA review panel - the closest regulatory comparables to K863819.
PERITONEAL CATHETERS
K902101 · Akcess Medical Products, Inc. · Jul 1990
PERITONEAL CATHETERS WITH AN ADDED FUNCTION
K890288 · Quinton, Inc. · Mar 1989
TRUDELL BENT CATHETER
K885167 · Sil-Med Corp. · Jan 1989
GORE-TEX PERITONEAL CATHETERR
K820909 · W.L. Gore & Associates, Inc. · May 1982
CUFF MATERIAL ON PEDIATRIC SIZE CATH.
K812718 · Quinton, Inc. · Oct 1981
TENCKHOFF PERITONEAL CATHETERS
K812607 · Quinton, Inc. · Oct 1981