Cadd-Tpn Administration Set, Model 21-7071
FDA 510(k) K991255 · Sims Deltec, Inc.
510(k) numberK991255
Submission
- Device name
- Cadd-Tpn Administration Set, Model 21-7071
- Applicant
- Sims Deltec, Inc.
St. Paul, MN, US - Received
- April 13, 1999
- Decision date
- June 9, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FPA – Set, Administration, Intravascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5440
- Specialty
- General Hospital
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More from B.Braun Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K010426 | Proport Plastic Venous Implantable Access Systems Pre-Assembled with Silicone CatheterLJT · Traditional | 03/08/2001SE |
| K000842 | Cadd-Prizm PCS II Model 6101 Ambulatory Infusion SystemFRN · Traditional | 06/08/2000SE |
| K000942 | Cadd Checkvalve Administration Set, Model 21-7090FPA · Traditional | 04/27/2000SE |
| K994216 | Plastic Port Implantable Venous Access SystemLJT · Traditional | 01/27/2000SE |
| K992697 | Port-A-Cath II Trans-Arterial Percutaneous SystemLJT · Traditional | 11/18/1999SE |
| K992880 | P.A.S. Port Elite Implantable Venous Access SystemLJT · Traditional | 10/19/1999SE |
| K991599 | Cadd Administration SetFPA · Traditional | 06/15/1999SE |
| K991301 | Cadd-Prizm High Volume Administration Set with 1.2 U Filter and Add-On Anti-Siphon…FPA · Traditional | 06/09/1999SE |
| K990083 | Cadd Administration Set, Cadd 250ML Flexible Medication Reservoir, Modified Securit…FPA · Traditional | 02/12/1999SE |
| K984055 | Clinicath Polyflow Polyurethane Peripherally Inserted CathetersFOZ · Traditional | 01/29/1999SE |
Questions and answers
When was Cadd-Tpn Administration Set, Model 21-7071 cleared by the FDA?
Cadd-Tpn Administration Set, Model 21-7071 (K991255) received a 510(k) decision of Substantially Equivalent on June 9, 1999, 57 days after the submission was received.
What is the product code of K991255?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.