MEDAMICUS COAXIAL INTRODUCER KIT, 10330-XXX, BOSTON SCIENTIFIC COAXIAL DILATOR SET— 510(k) K990705

Substantially Equivalent

Medamicus, Inc.

FDA 510(k) clearance K990705 for MEDAMICUS COAXIAL INTRODUCER KIT, 10330-XXX, BOSTON SCIENTIFIC COAXIAL DILATOR SET, Substantially Equivalent on 1999-06-28. Applicant: Medamicus, Inc.. Device class: 2.

Clearance details

Applicant: Medamicus, Inc.
Product code: Code DYB
Device class: Class 2
Regulation: 21 CFR 870.1340
Advisory panel: Cardiovascular
Date received: 1999-03-04
Decision date: 1999-06-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

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More clearances from Medamicus, Inc.

K040150 — MODIFICATION TO MEDAMICUS FLOWGUARD PEELABLE INTRODUCER2004-02-18
K030905 — MEDAMICUS FLOWGUARD PEELABLE INTRODUCER2003-04-09
K022689 — MODIFICATION TO MEDAMICUS AXIA RSN2002-08-23
K021004 — VALVED PEELABLE INTRODUCER2002-06-06
K020563 — MEDAMICUS AXIA RSN2002-05-21

Adverse events under product code DYB

product code DYB

Death: 808
Injury: 5,922
Malfunction: 16,516
Other: 5
Total: 23,251

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 →

Recalls naming K990705

K-number listed on FDA's recall record

Z-1614-2014 — Coaxial Micro-Introducer Kit. Greatbatch Part Number/Bard Access Systems Order Number/Part Description 10636-001 8004011 Kit Coax 10 Pack 4FR Bard 10636-002 8005011 Kit Coax 10 Pack 5FR Bard 10636-007 8004012 Kit Coax 10 Pack 4FR Bard 10636-008 8005012 Kit Coax 10 Pack 5FR Bard 10636-009 8004022 Kit Coax 10 Pack 5FR Bard 10636-010 8005022 Kit Coax 10 Pack 5FR Bard The Coaxial Micro-Introducer set contains a 21 gauge disposable introducer needle, 0.018 inch floppy tip guidewire, and a radiopaque Coaxial Micro Introducer consisting of a sheath and dilator. The Coaxial Micro-Introducer Set is used to introduce up to a 0.038 inch guidewire or catheter into the vascular system following a small 21 gauge needle stick.Class II·Terminated·Greatbatch Medical·20140428

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K990705.

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