SINGLE USE SELDINGER/COURNAND PERC. NDL— 510(k) K810859

Name: FDA 510(k) clearance K810859
Creator: U.S. Food and Drug Administration
Published: 1981-04-11

Substantially Equivalent

Procedure Products, Inc.

FDA 510(k) clearance K810859 for SINGLE USE SELDINGER/COURNAND PERC. NDL, Substantially Equivalent on 1981-04-11. Applicant: Procedure Products, Inc.. Device class: 2.

Clearance details

Applicant: Procedure Products, Inc.
Product code: Code DRE
Device class: Class 2
Regulation: 21 CFR 870.1310
Advisory panel: Cardiovascular
Date received: 1981-03-30
Decision date: 1981-04-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K161812 — Freedom Syringe2017-03-27
K923194 — INSUFFLATOR CONNECTING FILTER1993-10-08
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Adverse events under product code DRE

product code DRE

Death: 100
Injury: 832
Malfunction: 597
Other: 3
Total: 1,532

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 K810859

K-number listed on FDA's recall record

Z-0355-2016 — U-SDN 2 Part Ultra Modified Seldinger Needles, NS/37-0387. All needles were sold in bulk, non-sterile, and intended for further processing. Needles are packaged in zipper-bags, 300 pieces per bag, with shipment occurring in a corrugated cardboard box. Needles consist of a stainless steel cannula with a molded plastic hub. This needle is intended to be placed over the guidewire to enlarge the opening in the vessel. Vessel dilator, for percutaneous catheterization.Class II·Terminated·Procedure Products, Inc.·20151027

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K810859.

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