B. Braun IV Start Kits
FDA 510(k) K950184 · B. Braun of America, Inc.
510(k) numberK950184
Submission
- Device name
- B. Braun IV Start Kits
- Applicant
- B. Braun of America, Inc.
Bethlehem, PA, US - Received
- January 17, 1995
- Decision date
- March 15, 1995
- Decision
- Unknown (SEKD)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
| 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 |
| K925018 | IV Prep Kit W/O Dressing (Non-Sterile)LRS · Traditional | Customed, Inc. | 08/27/1993SEKD |
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| K983794 | Chemo Mini Spike PlusLHI · Traditional | 03/23/1999SE |
| K946170 | Comfort-Q Subcutaneous Injection SetsFOZ · Traditional | 11/03/1995SE |
| K945850 | Braun Diacan(R) Fistula NeedlesFIE · Traditional | 10/06/1995SE |
| K942988 | Filtered Extension SetsFPA · Traditional | 07/14/1995SE |
| K945752 | Celsite(Tm) Brachial Venous PortLJT · Traditional | 05/31/1995SE |
| K945551 | Celsite(Tm) Dual Venous SystemLJT · Traditional | 04/21/1995SE |
| K943770 | Low Volume MultiportFPA · Traditional | 04/10/1995SE |
| K950982 | B. Braun Sonocan Biopsy Needle and Aspiration HandleFCG · Traditional | 04/04/1995SE |
| K943181 | Dispensing Pin with One-Way ValveLHI · Traditional | 09/29/1994SE |
Questions and answers
When was B. Braun IV Start Kits cleared by the FDA?
B. Braun IV Start Kits (K950184) received a 510(k) decision of Unknown on March 15, 1995, 57 days after the submission was received.
What is the product code of K950184?
The FDA product code is LRS – I.V. Start Kit, a Class II (moderate risk) device regulated under 21 CFR 880.5200.