Cleared Traditional

K882383 - MAGGI SERIES ULTRA. NEEDLE, BIOPSY/CATHETER GUIDES

K882383 is an FDA 510(k) clearance for MAGGI SERIES ULTRA. NEEDLE, manufactured by CIVCO Medical Instruments Co., Inc.. The device is a Class 2 Cardiovascular device with product code DWZ cleared through the Traditional 510(k) pathway after a 172-day FDA review.

K882383 · CIVCO Medical Instruments Co., Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1988
Decision
172d
Days
Class 2
Risk

K882383 is an FDA 510(k) clearance for the MAGGI SERIES ULTRA. NEEDLE, BIOPSY/CATHETER GUIDES. Classified as Device, Biopsy, Endomyocardial (product code DWZ), Class II - Special Controls.

Submitted by CIVCO Medical Instruments Co., Inc. (Kalona, US). The FDA issued a Cleared decision on November 28, 1988 after a review of 172 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4075 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all CIVCO Medical Instruments Co., Inc. devices

FDA 510(k) Submission Details - K882383

510(k) Number K882383 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 1988
Decision Date November 28, 1988
Days to Decision 172 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
47d slower than avg
Panel avg: 125d · This submission: 172d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DWZ Device Classification - Class 2, Special Controls

Product Code DWZ Device, Biopsy, Endomyocardial
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4075
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.