Cleared Traditional

EXPANDED PTFE PROSTHESIS BLOOD ACCES (K823748) - FDA 510(k) Clearance

K823748 · C.R. Bard, Inc. · Gastroenterology & Urology device
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Feb 1983
Decision
66d
Days
-
Risk

K823748 is an FDA 510(k) clearance for the EXPANDED PTFE PROSTHESIS BLOOD ACCES.

Submitted by C.R. Bard, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 17, 1983 after a review of 66 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel. 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 C.R. Bard, Inc. devices

Submission Details

510(k) Number K823748 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 1982
Decision Date February 17, 1983
Days to Decision 66 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 130d · This submission: 66d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -