Cleared Traditional

K770403 - CATHETER-THRU-NEEDLE DEVICE

K770403 is an FDA 510(k) clearance for CATHETER-THRU-NEEDLE DEVICE, manufactured by Abbott Laboratories. The device is a Class 2 General Hospital device with product code FOZ cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K770403 · Abbott Laboratories · General Hospital
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Mar 1977
Decision
13d
Days
Class 2
Risk

K770403 is an FDA 510(k) clearance for the CATHETER-THRU-NEEDLE DEVICE. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on March 16, 1977 after a review of 13 days - a notably fast clearance cycle.

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: 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K770403

510(k) Number K770403 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1977
Decision Date March 16, 1977
Days to Decision 13 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
116d faster than avg
Panel avg: 129d · This submission: 13d
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 299
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K770403.
CATHETERS, OVER-THE-NEEDLE
K770751 · Cutter Laboratories, Inc. · May 1977
CANNULA, INTRAVENOUS, TEFLON
K770510 · Sherwood Medical Industries · May 1977
CANNULA, INTRAVENOUS, HEPARINIZED
K770511 · Sherwood Medical Industries · Apr 1977
KIT, CATHETER
K760319 · Jelco Laboratories · Aug 1976
CATHETER, INTRAVASCULAR (MEDICUT T)
K760163 · Sherwood Medical Industries · Jul 1976