STRYKER ANTIMIC CATHETER— 510(k) K072702

Name: FDA 510(k) clearance K072702
Creator: U.S. Food and Drug Administration
Published: 2008-03-19

Substantially Equivalent

Stryker Instruments, Instruments Div.

FDA 510(k) clearance K072702 for STRYKER ANTIMIC CATHETER, Substantially Equivalent on 2008-03-19. Applicant: Stryker Instruments, Instruments Div.. Device class: 2.

Clearance details

Applicant: Stryker Instruments, Instruments Div.
Product code: Code BSO
Device class: Class 2
Regulation: 21 CFR 868.5120
Advisory panel: Anesthesiology
Date received: 2007-09-24
Decision date: 2008-03-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kalamazoo, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code BSO

view all

K241410 — EDEN ControlCath2025-02-13
K231242 — Perifix FX Catheter; Contiplex FX Catheter2023-09-15
K230603 — Arrow Non-Stimulating SnapLock Adapter (K-05520-005C) +4 more2023-08-30
K193664 — SubQKath Catheter and Needle Set2020-09-09
K200624 — Percutaneous Introducer2020-04-27

More clearances from Stryker Instruments, Instruments Div.

view all

K123178 — STRYKER VENOM ELECTRODES AND CANNULAE2013-03-28
K113477 — IVAS 20MM (10 GAUGE) BALLOON CATHETER2012-01-06
K093419 — IVAS 2-10MM (10 GAUGE) BALLOON CATHETER, IVAS 2-15 MM(10 GAUGE)0705-115-500, IVAS 3-10MM(8 GAUGE)BALLOON CATHETER, IVAS2010-03-18
K073017 — STRYKER STRI-SHIELD FLYTE TOGAS2007-11-30
K070078 — STRYKER T4 HYTREL TOGA2007-02-02

Adverse events under product code BSO

product code BSO

Malfunction: 688
Total: 688

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.