Immobile Sterile and Immobile A/C Sterile
FDA 510(k) K941940 · Tnt Moborg Intl. , Ltd.
510(k) numberK941940
Submission
- Device name
- Immobile Sterile and Immobile A/C Sterile
- Applicant
- Tnt Moborg Intl. , Ltd.
Buffalo, NY, US - Received
- April 21, 1994
- Decision date
- July 14, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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
Other 510(k)s with product code KMK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| K943047 | IV Start KitsKMK · Traditional | Sterile Concepts, Inc. | 09/14/1994SE |
| 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 |
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Questions and answers
When was Immobile Sterile and Immobile A/C Sterile cleared by the FDA?
Immobile Sterile and Immobile A/C Sterile (K941940) received a 510(k) decision of Substantially Equivalent on July 14, 1994, 84 days after the submission was received.
What is the product code of K941940?
The FDA product code is KMK – Device, Intravascular Catheter Securement, a Class I (low risk) device regulated under 21 CFR 880.5210.