Deltec Systems, Inc.
United StatesFDA applicant, unverified
- Devices
- 9
What Deltec Systems, Inc. makes
Deltec Systems, Inc. manufactures ambulatory infusion pumps, including models like the CADD-VT, CADD-1 (5100 HF), CADD-PAC 5200, and CADD-LD 5500, designed for continuous or intermittent medication delivery outside a hospital setting. The company also produces accessories such as subclavian introducers, micro infusion sets, and AC adapter accessories for these devices. These products are intended for subcutaneous or intravenous administration of fluids and medications.
The company’s infusion pumps and accessories are classified as Class II medical devices under FDA regulations and are supported by 510(k) clearances. The devices are listed in the FDA’s 510(k) database, reflecting their regulatory pathway for marketing in the United States. Deltec Systems, Inc. is based in the US.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Cadd-1, Model 5100 Hf, Ambulatory Infusion Pump Ref K853584
Regimes: 510(k) Registry: 510(k)Ac Adapter Accessory, Product Code 600123A Ref K870768
Regimes: 510(k) Registry: 510(k)Cadd-1, Model 5100 Hf Ref K862927
Regimes: 510(k) Registry: 510(k)Pharmacia Deltec Subclavian Introducers Ref K871132
Regimes: 510(k) Registry: 510(k)Cadd-1 5100 Ambulatory Infusion Pump Ref K843772
Regimes: 510(k) Registry: 510(k)Cadd-Pac 5200 Ambulatory Infusion Pump Ref K843773
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Micro Infusion Set Ref K833949
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Deltec Systems, Inc. have in the registry?
The registry currently lists 9 devices for Deltec Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Deltec Systems, Inc.'s devices?
Among its 9 most recently registered devices, Deltec Systems, Inc. has devices listed in FDA 510(k) (9 devices).
What risk classes do Deltec Systems, Inc.'s devices fall under?
Among its 9 most recently registered devices, the classes recorded for Deltec Systems, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Deltec Systems, Inc. in the registry?
The most recently registered devices listed for Deltec Systems, Inc. include CADD-VT, 5300 AMBULATORY INFUSION PUMP W/3050, 50M, CADD-1, MODEL 5100 HF, AMBULATORY INFUSION PUMP, AC ADAPTER ACCESSORY, PRODUCT CODE 600123A and CADD-1, MODEL 5100 HF.