A P HARNESS— 510(k) K981860

Name: FDA 510(k) clearance K981860
Creator: U.S. Food and Drug Administration
Published: 1999-06-03

Substantially Equivalent

Paraworks Enterprise, Ltd.

FDA 510(k) clearance K981860 for A P HARNESS, Substantially Equivalent on 1999-06-03. Applicant: Paraworks Enterprise, Ltd.. Device class: 1.

Clearance details

Applicant: Paraworks Enterprise, Ltd.
Product code: Code KMK
Device class: Class 1
Regulation: 21 CFR 880.5210
Advisory panel: General Hospital
Date received: 1998-05-27
Decision date: 1999-06-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vancouver, British Columbia, CA

Download summary PDF View on FDA.gov ↗

Recent devices under product code KMK

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K180994 — SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, SecurAcath 7F/SecurAcath 8F2019-07-09
K963365 — MULTI-PURPOSE MEDICAL TUBE HOLDER1996-10-11
K941098 — SECURE-SITE1995-08-09
K943147 — STATLOCK CV1994-09-29
K943047 — IV START KITS1994-09-14

Adverse events under product code KMK

product code KMK

Malfunction: 461
Other: 1
Total: 462

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.