PRESSURE DISPLAY BOX #60000/TUBING SET #61000— 510(k) K852232

Name: FDA 510(k) clearance K852232
Creator: U.S. Food and Drug Administration
Published: 1985-08-09

Substantially Equivalent

Dlp, Inc.

FDA 510(k) clearance K852232 for PRESSURE DISPLAY BOX #60000/TUBING SET #61000, Substantially Equivalent on 1985-08-09. Applicant: Dlp, Inc.. Device class: 2.

Clearance details

Applicant: Dlp, Inc.
Product code: Code DXS
Device class: Class 2
Regulation: 21 CFR 870.4310
Advisory panel: Cardiovascular
Date received: 1985-05-22
Decision date: 1985-08-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Grand Rapids, MI, US

Download summary PDF View on FDA.gov ↗

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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

More clearances from Dlp, Inc.

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K973485 — CLEARVIEW BLOWER/MISTER1997-12-08
K964445 — OCTOPUS TISSUE STABILIZER (28001/28002/28003/28004/28005/28006)1997-01-30
K953945 — RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH ELONGATED & TREADED CUFF & INTRODUCER STYLET1996-03-26
K950754 — MACRO SUCTION TUBE MODEL NO 100611995-04-25
K934215 — CONTAIN-OR1994-02-09

Recalls naming K852232

K-number listed on FDA's recall record

Z-2768-2017 — DLP Pressure Disposable Pressure Display Sets Extends the pressure line in order to reach the pressure monitoring unit during cardiopulmonary bypass surgery.Class II·Terminated·Medtronic Perfusion Systems·20170622

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K852232.

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