Cleared Traditional

K961615 - LOW PROFILE TITANIUM PORT DETACHED CATH...

K961615 is an FDA 510(k) clearance for LOW PROFILE TITANIUM PORT DETACHED CATH..., manufactured by Arrow Intl., Inc.. The device is a Class 2 General Hospital device with product code LJT cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K961615 · Arrow Intl., Inc. · General Hospital
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Jul 1996
Decision
84d
Days
Class 2
Risk

K961615 is an FDA 510(k) clearance for the LOW PROFILE TITANIUM PORT DETACHED CATHETER SYSTEM CATALOG #1037. Classified as Port & Catheter, Implanted, Subcutaneous, Intravascular (product code LJT), Class II - Special Controls.

Submitted by Arrow Intl., Inc. (Walpole, US). The FDA issued a Cleared decision on July 19, 1996 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 880.5965 - 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 Arrow Intl., Inc. devices

FDA 510(k) Submission Details - K961615

510(k) Number K961615 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 1996
Decision Date July 19, 1996
Days to Decision 84 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
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.

LJT Device Classification - Class 2, Special Controls

Product Code LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5965
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 - LJT Port & Catheter, Implanted, Subcutaneous, Intravascular

All 125
Devices cleared under the same product code (LJT) and FDA review panel - the closest regulatory comparables to K961615.
A2 PORT, DUAL LUMEN SYSTEM WITH DETACHED CATHETER, CATALOG # AP-01518 (MODIFIED)
K963684 · Arrow Intl., Inc. · Oct 1996
PORT-A-CATH II VENOUS IMPLANTABLE ACCESS SYSTEMS PRECONNECTED WITH POLYURETHANE CATHETER
K962695 · Sims Deltec, Inc. · Oct 1996
PORT-A-CATH P.A.S. PORT II IMPLANTABLE VENOUS ACCESS SYTEMS
K961580 · Sims Deltec, Inc. · Sep 1996
LOW PROFILE PLASTIC PORT DETACHED CATHETER SYSTEM CATALOG #1017
K961652 · Arrow Intl., Inc. · Jul 1996
A PORT DETACHED CATHETER SYSTEM CATALOG #1002
K961583 · Arrow Intl., Inc. · Jul 1996
THEREX LOW PROFILE B PORT 1.0MM I.D./1.8MM O.D. DETACHED CATHETER
K960572 · Arrow Intl., Inc. · Apr 1996