Cleared Traditional

K880776 - 7 FR. TRIPLE LUMEN CENTRAL VEIN CATHETERI. SYSTEM (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K880776 · Medsurg Industries, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1988
Decision
66d
Days
Class 2
Risk

K880776 is an FDA 510(k) clearance for the 7 FR. TRIPLE LUMEN CENTRAL VEIN CATHETERI. SYSTEM. Classified as Cannula, Catheter (product code DQR), Class II - Special Controls.

Submitted by Medsurg Industries, Inc. (Herndon, US). The FDA issued a Cleared decision on May 2, 1988 after a review of 66 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1300 - 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 Medsurg Industries, Inc. devices

Submission Details

510(k) Number K880776 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 1988
Decision Date May 02, 1988
Days to Decision 66 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 125d · This submission: 66d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQR Cannula, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1300
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.