Microbore Extension Set
FDA 510(k) K942349 · Excelsior Medical Corp.
510(k) numberK942349
Submission
- Device name
- Microbore Extension Set
- Applicant
- Excelsior Medical Corp.
Long Branch, NJ, US - Received
- May 17, 1994
- Decision date
- February 8, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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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| K053120 | Sterile Field Saline and Heparin Lock Flush SyringesFOZ · Special | 12/09/2005SE |
| K023740 | Syrex Pre-Filled SyringeNZW · Traditional | 05/13/2003SE |
| K962938 | Excelsior Disposable Syringe W/Normal Saline (.9% Sodium Chloride)FOZ · Traditional | 10/25/1996SE |
Questions and answers
When was Microbore Extension Set cleared by the FDA?
Microbore Extension Set (K942349) received a 510(k) decision of Substantially Equivalent on February 8, 1995, 267 days after the submission was received.
What is the product code of K942349?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.