K923361 is an FDA 510(k) clearance for the I.V. START KIT, STERILE, DISPOSABLE. This device is classified as a I.v. Start Kit (Class II - Special Controls, product code LRS).
Submitted by Trinity Laboratories, Inc. (Salisbury, US). The FDA issued a Cleared decision on June 28, 1993, 355 days after receiving the submission on July 8, 1992.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 880.5200. 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..
| 510(k) Number | K923361 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - De Novo Granted (SEKD) |
| Date Received | July 08, 1992 |
| Decision Date | June 28, 1993 |
| Days to Decision | 355 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | LRS — I.v. Start Kit |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5200 |
| 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. |