VITAPATCH ANTIMICROBIAL CATHETER SECUREMENT DEVICE— 510(k) K895993

Name: FDA 510(k) clearance K895993
Creator: U.S. Food and Drug Administration
Published: 1990-01-11

Substantially Equivalent

Vitaphore Corp.

FDA 510(k) clearance K895993 for VITAPATCH ANTIMICROBIAL CATHETER SECUREMENT DEVICE, Substantially Equivalent on 1990-01-11. Applicant: Vitaphore Corp.. Device class: 1.

Clearance details

Applicant: Vitaphore Corp.
Product code: Code KMK
Device class: Class 1
Regulation: 21 CFR 880.5210
Advisory panel: General Hospital
Date received: 1989-10-13
Decision date: 1990-01-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Menlo Park, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KMK

view all

K180994 — SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, SecurAcath 7F/SecurAcath 8F2019-07-09
K981860 — A P HARNESS1999-06-03
K963365 — MULTI-PURPOSE MEDICAL TUBE HOLDER1996-10-11
K941098 — SECURE-SITE1995-08-09
K943147 — STATLOCK CV1994-09-29

More clearances from Vitaphore Corp.

view all

K914579 — SILVER FOAM WOUND DRESSING1992-02-21
K913148 — COLLAGEN SHIELD FOR ACUTE CARE1991-10-15
K895920 — VITAPATCH PIN PROTECTION DEVICE FOR PERCUTANEOUS1991-06-06
K902558 — COLLAGEN SHIELD FOR ACUTE CARE1990-08-17
K891993 — COLLAGEN NEUROSPONGE1990-03-23

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.