K001879 is an FDA 510(k) clearance for the INFUSION IV SET, a I.v. Start Kit (Class II — Special Controls, product code LRS), submitted by Nirvi Intl. USA (Pittsburg, US). The FDA issued a Cleared decision on November 20, 2001, 518 days after receiving the submission on June 20, 2000. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 880.5200.
| 510(k) Number | K001879 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 20, 2000 |
| Decision Date | November 20, 2001 |
| Days to Decision | 518 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. |