Cleared Traditional

K882969 - VASCULAR ACCESS PORT/CATHETER NO.VP-XXX...

K882969 is an FDA 510(k) clearance for VASCULAR ACCESS PORT/CATHETER NO.VP-XXX..., manufactured by Gish Biomedical, Inc.. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K882969 · Gish Biomedical, Inc. · Cardiovascular device
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Sep 1988
Decision
73d
Days
Class 2
Risk

K882969 is an FDA 510(k) clearance for the VASCULAR ACCESS PORT/CATHETER NO.VP-XXX VASPORT. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Gish Biomedical, Inc. (Santa Ana, US). The FDA issued a Cleared decision on September 26, 1988 after a review of 73 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - 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 Gish Biomedical, Inc. devices

FDA 510(k) Submission Details - K882969

510(k) Number K882969 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 1988
Decision Date September 26, 1988
Days to Decision 73 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
52d faster than avg
Panel avg: 125d · This submission: 73d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQY Device Classification - Class 2, Special Controls

Product Code DQY Catheter, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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 - DQY Catheter, Percutaneous

All 619
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K882969.
ACS SELECTIVE INFUSION CATHETER
K885237 · Advanced Cardiovascular Systems, Inc. · Mar 1989
ACS SOFT-TIP CORONARY INFUSION CATH W/SIDE HOLES
K883564 · Advanced Cardiovascular Systems, Inc. · Nov 1988
MULTI-MED INFUSION CATHETER AND KIT DOUBLE/TRIPLE
K883174 · Baxter Healthcare Corp · Oct 1988
ET HI-FLOW SOFT TIP/ET HI-FLOW/ENHANCED TORQUE ST
K882803 · Advanced Cardiovascular Systems, Inc. · Sep 1988
VEN-A-CATH PERCUTANEOUS VENOUS CATHETER KIT
K881504 · Hdc Corp. · Jun 1988
ACS HI-TORQUE CORONARY GUIDING CATHETER W/SOFT TIP
K874874 · Advanced Cardiovascular Systems, Inc. · Feb 1988