Cleared Traditional

K860806 - REGULATED PRESSURE INJECTOR

K860806 is an FDA 510(k) clearance for REGULATED PRESSURE INJECTOR, manufactured by Target Therapeutics. The device is a Class 2 Cardiovascular device with product code DXF cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K860806 · Target Therapeutics · Cardiovascular device
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Mar 1986
Decision
27d
Days
Class 2
Risk

K860806 is an FDA 510(k) clearance for the REGULATED PRESSURE INJECTOR. Classified as Catheter, Septostomy (product code DXF), Class II - Special Controls.

Submitted by Target Therapeutics (Los Angeles, US). The FDA issued a Cleared decision on March 31, 1986 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5175 - the FDA cardiovascular device oversight 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 Target Therapeutics devices

FDA 510(k) Submission Details - K860806

510(k) Number K860806 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 1986
Decision Date March 31, 1986
Days to Decision 27 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 125d · This submission: 27d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXF Device Classification - Class 2, Special Controls

Product Code DXF Catheter, Septostomy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5175
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DXF Catheter, Septostomy

All 20
Devices cleared under the same product code (DXF) and FDA review panel - the closest regulatory comparables to K860806.
PTA, PTV, ATRIOSEPTOSTOMY, ANGIOGRAPHIC, SIZING CATHETERS
K011557 · NuMED, Inc. · Jul 2001
BAYLIS MEDICAL RF SEPTOSTOMY GENERATOR, NYKANEN RF SEPTOSTOMY CATHETER, BAYLIS MEDICAL CONNECTOR CABLE
K990284 · Baylis Medical Co., Inc. · Feb 2001
NUMED Z-5 ATRIOSEPTOSTOMY CATHETER
K001804 · NuMED, Inc. · Jul 2000
BLADE SEPTOSTOMY CATHETER
K801031 · Cook, Inc. · Jul 1980