Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR

Viasys Medsystems

Wheeling, IL, US

Viasys Medsystems appears in FDA device records in Wheeling, IL. FDA records list 7 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.

FDA records held for this company

510(k) clearances
7
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 7 510(k) clearances for Viasys Medsystems between 2004 and 2008. The busiest year on record is 2005, with 3. The most recent is 2008, with 2.

Clearances by year, as a table
510(k) clearance decisions for Viasys Medsystems, by decision year
YearClearances
20041
20053
20071
20082
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K081725ENTERAL PUMP SET, MODEL 20-1010KNTSubstantially Equivalent
K080679MODIFICATION TO CORTRAK ENTERAL ACCESS DEVICE, MODEL 20-0900KNTSubstantially Equivalent
K063061CORTRAK ENTERAL ACCESS DEVICE, MODEL 20-0900KNTSubstantially Equivalent
K043044ANTI-I.V. ENTERAL FEEDING SYSTEMKNTSubstantially Equivalent
K050309PULMANEX DISPOSABLE PRESSURE MANOMETER, MODEL 50-5000CAPSubstantially Equivalent
K043004STACKHOUSE FREEDOMAIRE II SURGICAL HELMET SYSTEM, MODELS 12000, 12010, 12011, 12020, 12021, 12022, 12030, 12031FYASubstantially Equivalent
K041987CORTRAKKNTSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.

What MDM checks, and what it does not

MDM coverage

MDM coverage of this company lists here, newest first. Submit news.

Is this your company?

This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.

Claiming lets Viasys Medsystems edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.

The self-serve claim needs an FDA establishment registration, FEI or owner-operator number on the company’s record, and we hold none for Viasys Medsystems. The only route for a company with no identifier on record is a person here: write to us, and one looks at the record and sends the same claim link by hand.

Data as of , FDA export datePage updated Source: openFDA, public domain