Lo-Profile Extension Set
FDA 510(k) K915560 · Douglas Medical Products Corp.
510(k) numberK915560
Submission
- Device name
- Lo-Profile Extension Set
- Applicant
- Douglas Medical Products Corp.
Mundelein, IL, US - Received
- December 11, 1991
- Decision date
- May 14, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FPK – Tubing, Fluid Delivery
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5440
- Specialty
- General Hospital
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| K031808 | Medrad Swabbable Valve Transfer SetFPK · Special | Medrad, Inc. | 07/11/2003SE |
| K022431 | Medrad Transfer SetFPK · Traditional | Medrad, Inc. | 09/05/2002SE |
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| K953864 | Silclear Tubing (Modification)FPK · Traditional | Degania Silicone , Ltd. | 11/06/1995SE |
| K950508 | Sysmex SF-3000FPK · Traditional | Sysmex Corp. | 11/03/1995SE |
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Questions and answers
When was Lo-Profile Extension Set cleared by the FDA?
Lo-Profile Extension Set (K915560) received a 510(k) decision of Substantially Equivalent on May 14, 1992, 155 days after the submission was received.
What is the product code of K915560?
The FDA product code is FPK – Tubing, Fluid Delivery, a Class II (moderate risk) device regulated under 21 CFR 880.5440.