Tevadaptor; Connecting Set W/ Ultrasite Injection Site, Spike Port Adaptor Set W/ Ultrasite Injection Site
FDA 510(k) K141306 · Teva Medical Ltd., Migada Plant
510(k) numberK141306
Submission
- Device name
- Tevadaptor; Connecting Set W/ Ultrasite Injection Site, Spike Port Adaptor Set W/ Ultrasite Injection Site
- Applicant
- Teva Medical Ltd., Migada Plant
Rome, IT - Received
- May 19, 2014
- Decision date
- June 12, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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.
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|---|---|---|
| K180489 | TEVADAPTOR Closed Drug Reconstitution and Transfer SystemONB · Traditional | 09/21/2018SE |
| K170680 | TEVADAPTOR Closed Drug Reconstitution and Transfer SystemONB · Special | 05/16/2017SE |
| K141448 | Tevadaptor Closed Drug Reconstitution and Transfer SystemONB · Abbreviated | 01/23/2015SE |
Questions and answers
When was Tevadaptor; Connecting Set W/ Ultrasite Injection Site, Spike Port Adaptor Set W/ Ultrasite Injection Site cleared by the FDA?
Tevadaptor; Connecting Set W/ Ultrasite Injection Site, Spike Port Adaptor Set W/ Ultrasite Injection Site (K141306) received a 510(k) decision of Substantially Equivalent on June 12, 2014, 24 days after the submission was received.
What is the product code of K141306?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.