PRESSURE DISPLAY BOX,DLP DISPOSABLE PRESSURE DISPLAY SETS-NON STERILE VERSIONS— 510(k) K113235

Name: FDA 510(k) clearance K113235
Creator: U.S. Food and Drug Administration
Published: 2011-12-02

Substantially Equivalent

Medtronic, Inc.

FDA 510(k) clearance K113235 for PRESSURE DISPLAY BOX,DLP DISPOSABLE PRESSURE DISPLAY SETS-NON STERILE VERSIONS, Substantially Equivalent on 2011-12-02. Applicant: Medtronic, Inc.. Device class: 2.

Clearance details

Applicant: Medtronic, Inc.
Product code: Code DXS
Device class: Class 2
Regulation: 21 CFR 870.4310
Advisory panel: Cardiovascular
Date received: 2011-11-02
Decision date: 2011-12-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Mounds View, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DXS

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K944764 — VTI DISPOSABLE PRESSURE DISPLAY SET1994-12-27
K912045 — TMP PRESSURE ISOLATORR, TMP PRESSURE MONITOR SYST1991-10-31
K900797 — STOCKERT SHILEY DUAL PRESSURE CONTROL MODULE XR1990-05-10
K873802 — PRESSURE BARRIER KIT CAT. NO. PBK-31987-11-06
K862836 — STOCKERT-SHILEY CAPS AND CAPS DUAL PRESSURE MODULE1986-09-12

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Recalls naming K113235

K-number listed on FDA's recall record

Z-1802-2024 — Medtronic Disposable Pressure Display Sets: a) DLP¿ 114.3 cm (45 in), Model Number 61000; b) DLP¿ 114.3 cm (45 in), Model Number 62000Class II·Ongoing·Medtronic Perfusion Systems·20240319

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K113235.

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