Super-Spike Transfer Set
FDA 510(k) K802940 · Geneva Laboratories, Inc.
510(k) numberK802940
Submission
- Device name
- Super-Spike Transfer Set
- Applicant
- Geneva Laboratories, Inc.
Walker, MI, US - Received
- November 19, 1980
- Decision date
- January 15, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KSB – Set, Transfer (Blood/Plasma)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.9875
- Specialty
- Hematology
Other 510(k)s with product code KSB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K172957 | Kawasumi Laboratories Blood Drawing Kit (BDK) SystemKSB · Traditional | Kawasumi Laboratories, Inc. | 09/28/2018SE |
| K001043 | Kawasumi Laboratory Blood Drawing KitKSB · Traditional | Kawasumi Laboratories America, Inc. | 05/19/2000SE |
| K820447 | Alpha Plasma Transfer SetKSB · Traditional | Alpha Therapeutic Corp. | 04/14/1982SE |
| K791131 | Flu Ven TR-1KSB · Traditional | Venospital, Inc. | 09/04/1979SE |
| K791130 | Flu-Ven TK-2KSB · Traditional | Venospital, Inc. | 09/04/1979SE |
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| 510(k) | Device | Decision |
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| K881218 | Gent-L-Kare Cleansing Enema SetFCE · Traditional | 07/28/1988SE |
| K881213 | Gent-L-Kare Sterile Urinary Drainage Bag CenterKNX · Traditional | 07/28/1988SE |
| K881216 | Gent-L-Kare Vaginal Irrigation SetHED · Traditional | 06/07/1988SE |
| K861308 | Accupac Custom Pack Kerlix SquaresEFQ · Traditional | 05/02/1986SE |
| K861219 | Accupac Custom Skin Scrub Kit · Traditional | 04/15/1986SE |
| K853265 | Accupac Custom Operating Room PROCEDURE-DK876543 · Traditional | 08/26/1985SE |
| K843206 | Cook County Hospital Dressing Change SetKDD · Traditional | 05/24/1985SE |
| K844255 | Gent-L-Kare Sterile I.V. Start KitFPA · Traditional | 12/19/1984SE |
| K843090 | University of Chicago Vascular AngiogramFPA · Traditional | 12/04/1984SE |
Questions and answers
When was Super-Spike Transfer Set cleared by the FDA?
Super-Spike Transfer Set (K802940) received a 510(k) decision of Substantially Equivalent on January 15, 1981, 57 days after the submission was received.
What is the product code of K802940?
The FDA product code is KSB – Set, Transfer (Blood/Plasma), a Class II (moderate risk) device regulated under 21 CFR 864.9875.