IV Start Kit
FDA 510(k) K914475 · Cypress Medical Products, Ltd.
510(k) numberK914475
Submission
- Device name
- IV Start Kit
- Applicant
- Cypress Medical Products, Ltd.
Mc Henry, IL, US - Received
- October 8, 1991
- Decision date
- March 18, 1992
- 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 |
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| K972899 | Cypress Medical Products Aneroid SphygmomanometerDXQ · Traditional | 07/07/1998SE |
| K972849 | Isosafe Earloop Procedure Mask (Blue, Yellow)FXX · Traditional | 05/28/1998SE |
| K972883 | Isosafe Earloop Procedure Mask (Blue, Yellow)FXX · Traditional | 02/26/1998SE |
| K952367 | Cypress Medical Products Vinyl Examination GloveLYY · Traditional | 07/05/1995SE |
| K950254 | Cypress Medical Products Sterile Latex Examination GloveLYY · Traditional | 03/31/1995SE |
| K950109 | Cypress Medical Products Catheter (Insertion) Tray/With Out CatheterFCM · Traditional | 02/27/1995SESK |
| K950092 | Cypress Medical Products Catheter (Insertion) TrayFCM · Traditional | 02/27/1995SESK |
| K945082 | Cypress Medical Products StethoscopeLDE · Traditional | 12/08/1994SE |
Questions and answers
When was IV Start Kit cleared by the FDA?
IV Start Kit (K914475) received a 510(k) decision of Unknown on March 18, 1992, 162 days after the submission was received.
What is the product code of K914475?
The FDA product code is LRS – I.V. Start Kit, a Class II (moderate risk) device regulated under 21 CFR 880.5200.