Quick-Draw Capillary Whole Blood Collection System
FDA 510(k) K972969 · Innovative Medical Technologies, Inc.
510(k) numberK972969
Submission
- Device name
- Quick-Draw Capillary Whole Blood Collection System
- Applicant
- Innovative Medical Technologies, Inc.
Lenexa, KS, US - Received
- August 11, 1997
- Decision date
- September 22, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GIO – Tube, Collection, Capillary Blood
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.6150
- Specialty
- Hematology
Other 510(k)s with product code GIO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K941291 | Monoject Samplette Separator TubeGIO · Traditional | Sherwood Medical Co. | 10/27/1994SE |
| K894851 | Tru-TraxGIO · Traditional | Humagen, Inc. | 09/29/1989SE |
| K885324 | Hema(Pro)Tec(Tion)GIO · Traditional | Medical Products Search, Inc. | 02/17/1989SE |
| K885138 | Capillary Tube, Blood CollectionGIO · Traditional | Coeur Laboratories, Inc. | 02/07/1989SE |
| K884623 | Safe-Tec Capillary Blood Collection TubeGIO · Traditional | Safe-Tec Clinical Products, Inc. | 12/01/1988SE |
| K881262 | Caraway Tubes, Heparin and PlainGIO · Traditional | Helps Products, Inc. | 05/06/1988SE |
| K881187 | Natelson Tubes, Heparin and PlainGIO · Traditional | Helps Products, Inc. | 05/06/1988SE |
| K875061 | Monoject Samplette Amber Capillary Serum SeparatorGIO · Traditional | Sherwood Medical Co. | 01/12/1988SE |
| K873647 | Ventrescreen Capillary Blood Collection TubeGIO · Traditional | Ventrex Laboratories, Inc. | 10/20/1987SE |
| K850806 | Corning Blood Collection Capillary TubesGIO · Traditional | Corning Medical & Scientific | 03/25/1985SE |
More from Corning Medical & Scientific
| 510(k) | Device | Decision |
|---|---|---|
| K220458 | UltraFlo-R Push Button Blood Collection SetJKA · Traditional | 09/29/2023SE |
| K123987 | Improve Blood Collection Set and Improsafe Blood Collection SetJKA · Traditional | 08/27/2013SE |
| K936087 | Carpal BoxKPR · Traditional | 10/20/1994SE |
| K904237 | Rapid Immobilization Device or R.I.D. SystemFPP · Traditional | 05/09/1991SE |
| K854194 | Imt Ultrasonic Stride Monitor · Traditional | 05/02/1986SE |
Questions and answers
When was Quick-Draw Capillary Whole Blood Collection System cleared by the FDA?
Quick-Draw Capillary Whole Blood Collection System (K972969) received a 510(k) decision of Substantially Equivalent on September 22, 1997, 42 days after the submission was received.
What is the product code of K972969?
The FDA product code is GIO – Tube, Collection, Capillary Blood, a Class I (low risk) device regulated under 21 CFR 864.6150.