LRS — I.V. Start Kit Class II
Classification Details
- Product Code
- LRS
- Device Class
- Class II
- Regulation Number
- 880.5200
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General Hospital
- Implant
- No
Definition
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 (510(k)) to market if it meets all criteria in the guidance.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K050654 | amsino international | AMSINO I.V. START KIT | May 2, 2005 |
| K001879 | nirvi intl. usa | INFUSION IV SET | November 20, 2001 |
| K963722 | grand medical products | IV START KIT | November 27, 1996 |
| K951167 | emergency medical supply | EMS I.V. START KIT | May 16, 1995 |
| K950184 | b. braun of america | B. BRAUN IV START KITS | March 15, 1995 |
| K944041 | resound | PERSONAL HEARING SYSTEM | December 27, 1994 |
| K943941 | becton dickinson vascular access | SAFESTART VASCULAR ACCESS START KIT | October 20, 1994 |
| K935684 | cush medical products | IV START KIT | June 10, 1994 |
| K942238 | bd becton dickinson vacutainer systems preanalytic | I.V. STARTPAK VASCULAR ACCESS START KIT | June 3, 1994 |
| K941469 | clinical resources | IV START KIT | May 12, 1994 |
| K925018 | customed | IV PREP KIT W/O DRESSING (NON-STERILE) | August 27, 1993 |
| K925017 | customed | IV PREP KIT (NON-STERILE) | August 27, 1993 |
| K933041 | electone | COLD CD ASP MODULE, ITE | August 2, 1993 |
| K924538 | cml | IV START KIT | July 2, 1993 |
| K930196 | medi-flex hospital products | CEPTI-SEAL I.V. PREP KIT | July 2, 1993 |
| K923361 | trinity laboratories | I.V. START KIT, STERILE, DISPOSABLE | June 28, 1993 |
| K924811 | transidyne general | I.V. START KIT | June 17, 1993 |
| K926031 | brigam medical | PRO-PREP I.V. START/SCRUB-PREP/BLOOD CULTURE KIT | June 7, 1993 |
| K922533 | specialty medical products | IV START KIT CUSTOM SMP # A-Z | March 23, 1993 |
| K914475 | cypress medical products | IV START KIT | March 18, 1992 |