Durham; Luer Lock Extension Set
FDA 510(k) K930410 · Intl. Medical, Inc.
510(k) numberK930410
Submission
- Device name
- Durham; Luer Lock Extension Set
- Applicant
- Intl. Medical, Inc.
Washington Crossing, PA, US - Received
- January 26, 1993
- Decision date
- September 3, 1993
- 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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| 510(k) | Device | Decision |
|---|---|---|
| K970507 | Peak Flow MeterBZH · Traditional | 06/13/1997SE |
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| K940370 | American Catheter E.R.C.P. CannulaFGE · Traditional | 08/17/1994SE |
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| K942068 | American Catheter SphincterotomeKNS · Traditional | 06/24/1994SE |
| K930406 | Durham; Min Bore Luer Lock Extension SetFPA · Traditional | 09/03/1993SE |
| K923200 | Amcath Disposable Cytology BrushFDX · Traditional | 12/07/1992SE |
| K915142 | Amcath Disposable Biopsy ForcepsFCF · Traditional | 01/10/1992SE |
| K912927 | Amcath Disposable Trocar and Trocar SleeveGCJ · Traditional | 09/19/1991SE |
| K912605 | Amcath Disposable Micro ScissorsGCJ · Traditional | 07/11/1991SE |
Questions and answers
When was Durham; Luer Lock Extension Set cleared by the FDA?
Durham; Luer Lock Extension Set (K930410) received a 510(k) decision of Substantially Equivalent on September 3, 1993, 220 days after the submission was received.
What is the product code of K930410?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.