Cepti-Seal I.V. Prep Kit
FDA 510(k) K930196 · Medi-Flex Hospital Products, Inc.
510(k) numberK930196
Submission
- Device name
- Cepti-Seal I.V. Prep Kit
- Applicant
- Medi-Flex Hospital Products, Inc.
Overland Park, KS, US - Received
- January 14, 1993
- Decision date
- July 2, 1993
- Decision
- Unknown (SEKD)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LRS – I.V. Start Kit
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5200
- Specialty
- General Hospital
This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification…
Other 510(k)s with product code LRS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K050654 | Amsino I.V. Start KitLRS · Traditional | Amsino International, Inc. | 05/02/2005SE |
| K001879 | Infusion IV SetLRS · Traditional | Nirvi Intl. USA | 11/20/2001SE |
| K963722 | IV Start KitLRS · Traditional | Grand Medical Products | 11/27/1996SE |
| K951167 | EMS I.V. Start KitLRS · Traditional | Emergency Medical Supply, Inc. | 05/16/1995SN |
| K950184 | B. Braun IV Start KitsLRS · Traditional | B. Braun of America, Inc. | 03/15/1995SEKD |
| K944041 | Personal Hearing SystemLRS · Traditional | Resound Corp. | 12/27/1994SE |
| K943941 | Safestart Vascular Access Start KitLRS · Traditional | Becton Dickinson Vascular Access, Inc. | 10/20/1994SE |
| K935684 | IV Start KitLRS · Traditional | Cush Medical Products | 06/10/1994SEKD |
| K942238 | I.V. Startpak Vascular Access Start KitLRS · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 06/03/1994SE |
| K941469 | IV Start KitLRS · Traditional | Clinical Resources, Inc. | 05/12/1994SE |
More from Clinical Resources, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K970441 | K-Klosure 2 Inch LENGTH/4 Inch LENGTH/8 Inch LENGTH/12 Inch LengthFPX · Traditional | 05/09/1997SE |
| K962740 | Dermistick Sepp APPLICATOR(200 CT)/(40 CT) 260640/260641KMF · Traditional | 09/06/1996SE |
| K952201 | Port-A-Cath Access KitFMF · Traditional | 10/04/1995SE |
| K952416 | Tracheostomy Care KitBTO · Traditional | 08/09/1995SESK |
| K952256 | Picc Line KitFOZ · Traditional | 07/31/1995SE |
| K952007 | Adherol Sepp ApplicatorFRO · Traditional | 06/08/1995SE |
| K934790 | Sepp Adhesive RemoverKOX · Traditional | 03/11/1994SE |
| K923516 | Compound Benzoin Tincture Usp SeppKMF · Traditional | 01/25/1994SE |
| K920399 | Compound Benzoin Tincture Usp FreppKMF · Traditional | 01/25/1994SE |
| K921347 | Cepti-Seal Dressing Change Kit for Venous CatheterMCY · Traditional | 01/08/1993SEKD |
Questions and answers
When was Cepti-Seal I.V. Prep Kit cleared by the FDA?
Cepti-Seal I.V. Prep Kit (K930196) received a 510(k) decision of Unknown on July 2, 1993, 169 days after the submission was received.
What is the product code of K930196?
The FDA product code is LRS – I.V. Start Kit, a Class II (moderate risk) device regulated under 21 CFR 880.5200.