DeviceClearance

REF. 4102CV INTERMEDIARY TUBING, REF. 4509CV STERILE ZONE KIT— 510(k) K951843

Substantially Equivalent

Future Medical Systems, Inc.

FDA 510(k) clearance K951843 for REF. 4102CV INTERMEDIARY TUBING, REF. 4509CV STERILE ZONE KIT, Substantially Equivalent on 1995-07-14. Applicant: Future Medical Systems, Inc.. Device class: 2.

Clearance details

Applicant
Future Medical Systems, Inc.
Product code
Code HRX
Device class
Class 2
Regulation
21 CFR 888.1100
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
New York City, NY, US
Download summary PDFView on FDA.gov ↗

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More clearances from Future Medical Systems, Inc.

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Adverse events under product code HRX

product code HRX
Injury
623
Malfunction
11,257
Total
11,880

Source: openFDA MAUDE database, through . 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 K951843

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K951843.

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