Cleared Traditional

K811964 - VISITEC NEEDLE RANGE (CARDIOVASCULAR)

K811964 is an FDA 510(k) clearance for VISITEC NEEDLE RANGE (CARDIOVASCULAR), manufactured by Visitec Co.. The device is a Class 2 Cardiovascular device with product code DRC cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K811964 · Visitec Co. · Cardiovascular device
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Jul 1981
Decision
10d
Days
Class 2
Risk

K811964 is an FDA 510(k) clearance for the VISITEC NEEDLE RANGE (CARDIOVASCULAR). Classified as Trocar (product code DRC), Class II - Special Controls.

Submitted by Visitec Co. (Mchenry, US). The FDA issued a Cleared decision on July 20, 1981 after a review of 10 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1390 - 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 Visitec Co. devices

FDA 510(k) Submission Details - K811964

510(k) Number K811964 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 1981
Decision Date July 20, 1981
Days to Decision 10 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
115d faster than avg
Panel avg: 125d · This submission: 10d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRC Device Classification - Class 2, Special Controls

Product Code DRC Trocar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1390
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 - DRC Trocar

All 30
Devices cleared under the same product code (DRC) and FDA review panel - the closest regulatory comparables to K811964.
NAMIC ONE PART INTRODUCER NEEDLE
K871382 · North American Instrument Corp. · May 1987
MEDSURG POTT-COURNAND NEEDLE
K854293 · Medsurg Industries, Inc. · Jan 1986
MEDSURG SELDINGER NEEDLE
K854294 · Medsurg Industries, Inc. · Jan 1986
DILUTION KIT, THERMAL, COLD PAC
K781221 · Instrumentation Laboratory CO · Aug 1978
NEEDLES USED IN ANGIOGRAPHIC PROCED.
K772369 · Argon Medical Corp. · Jan 1978
ADVANSET
K771261 · C.R. Bard, Inc. · Aug 1977