Cleared Traditional

K861829 - CURITY CENTRAL VENOUS CATHETER

K861829 is an FDA 510(k) clearance for CURITY CENTRAL VENOUS CATHETER, manufactured by The Kendal Co.. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K861829 · The Kendal Co. · Cardiovascular device
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Jul 1986
Decision
59d
Days
Class 2
Risk

K861829 is an FDA 510(k) clearance for the CURITY CENTRAL VENOUS CATHETER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by The Kendal Co. (Boston, US). The FDA issued a Cleared decision on July 10, 1986 after a review of 59 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 The Kendal Co. devices

FDA 510(k) Submission Details - K861829

510(k) Number K861829 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 1986
Decision Date July 10, 1986
Days to Decision 59 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
66d faster than avg
Panel avg: 125d · This submission: 59d
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 K861829.
[CENTRAL VENOUS][MULTI-LUMEN] CATHETER W/FLEX TIP
K862056 · Arrow Intl., Inc. · Aug 1986
CURITY CENTRAL VENOUS CATHETERIZATION TRAY
K861827 · The Kendal Co. · Jul 1986
CURITY VENOUS CATHETERIZATION KIT
K861828 · The Kendal Co. · Jul 1986
VASCULAR ACCESS PORT/CATH CAT.#VP-XXXX VASPORT SER
K854610 · Gish Biomedical, Inc. · May 1986
PHARMASEAL DUAL LUMEN CATHETER
K861165 · American Pharmaseal Div. Ahsc · May 1986
BARD PARKER PERFUSION CATHETER
K855201 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1986