Data / Medical devices / Italy / ICU Medical (SM Prodotti) Italia S.r.L.
ICU Medical (SM Prodotti) Italia S.r.L.: FDA-registered device maker in Latina Scalo - LT, Italy, 1 510(k) clearance
ICU Medical (SM Prodotti) Italia S.r.L. is registered with the FDA (registration 3004187702) in Latina Scalo - LT, Italy. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated August 20, 1999. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3004187702
- Address
- Via della Stazione, 2, Latina Scalo - LT, Italy, 04100
- Owner or operator
- ICU Medical, Inc. (8020727)
- Roles
- Manufacturer
- First device listed
- November 28, 2007
- Registered through
- 2026
- Brand names listed
- Cathlon, Jelco, Jelco ProtectIV Plus-W Safety IV Catheter, Jelco ProtectIV-W Safety IV Catheter, Jelco-W I.V. Catheter, Optiva, PROTECTIV
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 20, 1999 | K990236 | MODIFICATION OF JELCO*,JELCO*-W AND JELCO* PLUS I.V. CATHETERS, CATHLON* I.V. CATHETERS, OPTIVA* I.V. CATHETERS, PROTECT | FOZ | Substantially Equivalent | Johnson & Johnson Medical, Div. of Ethicon, Inc. | accessdata.fda.gov |
Compare with other makers
Updated August 20, 1999. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.