Jostra AG
Newark, DE, US
Jostra AG appears in FDA device records in Newark, DE. FDA records list 14 510(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
- 14
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 14 510(k) clearances for Jostra AG between 2000 and 2004. The busiest year on record is 2002, with 5. The most recent is 2004, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2000 | 1 |
| 2001 | 4 |
| 2002 | 5 |
| 2003 | 3 |
| 2004 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K020983 | JOSTRA SUCKERS, MODEL JS | DWF | Substantially Equivalent | |
| K031544 | HEATER COOLER UNIT, MODEL HCU 30 | DWC | Substantially Equivalent | |
| K030264 | QUANDROX SAFELINE HOLLOW FIBER MEMBRANE OXYGENATOR, MODEL HMO 2030 | DTZ | Substantially Equivalent | |
| K020784 | JOSTRA SINGLE STAGE VENOUS RETURN CATHETERS | DWF | Substantially Equivalent | |
| K023132 | JOSTRA MECC SYSTEM | KFM | Substantially Equivalent | |
| K022022 | JOSTRA VENT CATHETERS, MODELS LV & HKV | DWF | Substantially Equivalent | |
| K020515 | JOSTRA ANTEGRADE CARDIOPLEGIA CANNULA | DWF | Substantially Equivalent | |
| K014303 | JOSTRA RETROGRADE CARDIOPLEGIA CANNULAE | DWF | Substantially Equivalent | |
| K013944 | JOSTRA DUAL STAGE VENOUS RETURN CANNULAE | DWF | Substantially Equivalent | |
| K013939 | JOSTRA FLOWPROBE FP-32E | DPT | Substantially Equivalent | |
| K012774 | JOSTRA ARTERIAL PERFUSION CANNULAE | DWF | Substantially Equivalent | |
| K012617 | JOSTRA ARTERIAL PERFUSION CANNULAE, MODEL A... | DWF | Substantially Equivalent | |
| K003551 | VENOUS HARDSHELL CARDIOTOMY RESEVOIR, MODEL VHK 4201 | DTN | Substantially Equivalent | |
| K002857 | ELS CANNULA (KIT), MODEL M1210-88,M1510-88 | DWF | Substantially 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.
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 Jostra AG 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 Jostra AG. 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