Conmed Veni-Gard I.V. Dressing
FDA 510(k) K935389 · Conmedcorp
510(k) numberK935389
Submission
- Device name
- Conmed Veni-Gard I.V. Dressing
- Applicant
- Conmedcorp
Utica, NY, US - Received
- November 8, 1993
- Decision date
- March 7, 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 |
| 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 |
| 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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| K101534 | Conmed Altrus Thermal Tissue Fusion SystemGEI · Traditional | 11/24/2010SE |
| K061021 | Entake Standard and Safety Peg SystemKNT · Traditional | 04/28/2006SE |
| K050992 | Conmed Irrigation NozzleKPL · Traditional | 07/14/2005SE |
| K050777 | Proforma HF 4.5 Cannula, Model 050906, 050907FGE · Special | 04/22/2005SE |
| K050304 | FX Wire Advanced Measurement GuidewireOCY · Special | 03/08/2005SE |
| K041953 | Versastim, Perfoamax, Surgi-Stim, FaststartGXY · Special | 08/09/2004SE |
| K021079 | Abcsnare Electrosurgical Probe for Flexible Endoscopes, Model 1336XXGEI · Traditional | 07/01/2002SE |
| K021299 | Conmed Heatwave Hand-Controlled EletrodeGEI · Traditional | 06/26/2002SE |
| K020186 | Conmed System 5000 EsuGEI · Traditional | 04/12/2002SE |
| K020135 | Conmed System 2000 Electrosurgical Generator, Ref: 60-8002; Conmed Esu Cart, Ref: 60-6120GEI · Traditional | 04/12/2002SE |
Questions and answers
When was Conmed Veni-Gard I.V. Dressing cleared by the FDA?
Conmed Veni-Gard I.V. Dressing (K935389) received a 510(k) decision of Substantially Equivalent on March 7, 1994, 119 days after the submission was received.
What is the product code of K935389?
The FDA product code is KMK – Device, Intravascular Catheter Securement, a Class I (low risk) device regulated under 21 CFR 880.5210.