Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR

Deltec Systems, Inc.

Walker, MI, US

Deltec Systems, Inc. appears in FDA device records in Walker, MI. FDA records list 9 510(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
9
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 9 510(k) clearances for Deltec Systems, Inc. between 1984 and 1987. The busiest year on record is 1984, with 3. The most recent is 1987, with 2.

Clearances by year, as a table
510(k) clearance decisions for Deltec Systems, Inc., by decision year
YearClearances
19843
19852
19862
19872
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K871132PHARMACIA DELTEC SUBCLAVIAN INTRODUCERSDYBSubstantially Equivalent
K870768AC ADAPTER ACCESSORY, PRODUCT CODE 600123AFRNSubstantially Equivalent
K862927CADD-1, MODEL 5100 HFFRNSubstantially Equivalent
K854964CADD-LD 5500 AMBU INFUSION PUMP&3010 10ML MED RES.FRNSubstantially Equivalent
K853584CADD-1, MODEL 5100 HF, AMBULATORY INFUSION PUMPFRNSubstantially Equivalent
K850183CADD-VT, 5300 AMBULATORY INFUSION PUMP W/3050, 50MFRNSubstantially Equivalent
K843773CADD-PAC 5200 AMBULATORY INFUSION PUMPFRNSubstantially Equivalent
K843772CADD-1 5100 AMBULATORY INFUSION PUMPFRNSubstantially Equivalent
K833949MICRO INFUSION SETFPASubstantially 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 Deltec Systems, Inc. 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 Deltec Systems, Inc.. 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