IV Start Kits
FDA 510(k) K943047 · Sterile Concepts, Inc.
510(k) numberK943047
Submission
- Device name
- IV Start Kits
- Applicant
- Sterile Concepts, Inc.
Richmond, VA, US - Received
- June 27, 1994
- Decision date
- September 14, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KMK – Device, Intravascular Catheter Securement
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.5210
- Specialty
- General Hospital
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|---|---|---|---|
| K180994 | SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, SecurAcath…KMK · Traditional | Interrad Medical, Inc. | 07/09/2019SE |
| K981860 | A P HarnessKMK · Traditional | Paraworks Enterprise, Ltd. | 06/03/1999SE |
| K963365 | Multi-Purpose Medical Tube HolderKMK · Traditional | Byrd Medical Devices, Inc. | 10/11/1996SE |
| K941098 | Secure-SiteKMK · Traditional | Op-Co Medical Products , Ltd. | 08/09/1995SE |
| K943147 | Statlock CVKMK · Traditional | Venetec, Inc. | 09/29/1994SE |
| K941940 | Immobile Sterile and Immobile A/C SterileKMK · Traditional | Tnt Moborg Intl. , Ltd. | 07/14/1994SE |
| K941850 | Immobile Non-Sterile and Immobile A/C Non-SterileKMK · Traditional | Tnt Moborg Intl. , Ltd. | 07/14/1994SE |
| K935389 | Conmed Veni-Gard I.V. DressingKMK · Traditional | Conmedcorp | 03/07/1994SE |
| K935252 | K-Lok Catheter Securement Device ModificationKMK · Traditional | K-Lok, Inc. | 02/18/1994SE |
| K940127 | Centermark Securing WingsKMK · Traditional | Menlo Care, Inc. | 02/09/1994SE |
More from Menlo Care, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K951231 | Orthopedic PacksGAN · Traditional | 12/01/1995SE |
| K951081 | OB/GYN PacksKNA · Traditional | 11/13/1995SE |
| K952539 | Radiology PacksLRO · Traditional | 07/14/1995SE |
| K951478 | General and Plastic Surgery PacksLRO · Traditional | 06/13/1995SE |
| K944139 | Dental Hygiene TrayLYY · Traditional | 12/15/1994SE |
| K943090 | Suture Removal TraysFRG · Traditional | 08/22/1994SEKD |
| K940864 | Dentist with Assistant PackEIA · Traditional | 08/02/1994SE |
| K943046 | Skin Staple Removal TraysMCZ · Traditional | 07/29/1994SESK |
| K920763 | Lacerattion TrayKDD · Traditional | 09/28/1992SESK |
Questions and answers
When was IV Start Kits cleared by the FDA?
IV Start Kits (K943047) received a 510(k) decision of Substantially Equivalent on September 14, 1994, 79 days after the submission was received.
What is the product code of K943047?
The FDA product code is KMK – Device, Intravascular Catheter Securement, a Class I (low risk) device regulated under 21 CFR 880.5210.