LRS · I.V. Start Kit
General Hospital · 21 CFR 880.5200 · Class 2
Overview
| Product Code | LRS |
|---|---|
| Device Name | I.V. Start Kit |
| Regulation | 21 CFR 880.5200 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
Identification
An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 30)
Showing 20 most recent of 30 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K050654 | AMSINO I.V. START KIT | Amsino International, Inc. | May 2, 2005 | SESE |
| K001879 | INFUSION IV SET | Nirvi Intl. USA | Nov 20, 2001 | SESE |
| K963722 | IV START KIT | Grand Medical Products | Nov 27, 1996 | SESE |
| K951167 | EMS I.V. START KIT | Emergency Medical Supply, Inc. | May 16, 1995 | SN |
| K950184 | B. BRAUN IV START KITS | B. Braun of America, Inc. | Mar 15, 1995 | SEKD |
| K944041 | PERSONAL HEARING SYSTEM | Resound Corp. | Dec 27, 1994 | SESE |
| K943941 | SAFESTART VASCULAR ACCESS START KIT | Becton Dickinson Vascular Access, Inc. | Oct 20, 1994 | SESE |
| K935684 | IV START KIT | Cush Medical Products | Jun 10, 1994 | SEKD |
| K942238 | I.V. STARTPAK VASCULAR ACCESS START KIT | Bd Becton Dickinson Vacutainer Systems Preanalytic | Jun 3, 1994 | SESE |
| K941469 | IV START KIT | Clinical Resources, Inc. | May 12, 1994 | SESE |
| K925018 | IV PREP KIT W/O DRESSING (NON-STERILE) | Customed, Inc. | Aug 27, 1993 | SEKD |
| K925017 | IV PREP KIT (NON-STERILE) | Customed, Inc. | Aug 27, 1993 | SESE |
| K933041 | COLD CD ASP MODULE, ITE | Electone, Inc. | Aug 2, 1993 | SESE |
| K930196 | CEPTI-SEAL I.V. PREP KIT | Medi-Flex Hospital Products, Inc. | Jul 2, 1993 | SEKD |
| K924538 | IV START KIT | Cml, Inc. | Jul 2, 1993 | SEKD |
| K923361 | I.V. START KIT, STERILE, DISPOSABLE | Trinity Laboratories, Inc. | Jun 28, 1993 | SEKD |
| K924811 | I.V. START KIT | Transidyne General Corp. | Jun 17, 1993 | SEKD |
| K926031 | PRO-PREP I.V. START/SCRUB-PREP/BLOOD CULTURE KIT | Brigam Medical, Inc. | Jun 7, 1993 | SEKD |
| K922533 | IV START KIT CUSTOM SMP # A-Z | Specialty Medical Products Co. | Mar 23, 1993 | SEKD |
| K914475 | IV START KIT | Cypress Medical Products, Ltd. | Mar 18, 1992 | SEKD |
Top Applicants
- Customed, Inc. — 2 clearances
- American Biomaterials Corp. — 1 clearance
- Amsino International, Inc. — 1 clearance
- B. Braun of America, Inc. — 1 clearance
- Bd Becton Dickinson Vacutainer Systems Preanalytic — 1 clearance
