K921347 is an FDA 510(k) clearance for the CEPTI-SEAL DRESSING CHANGE KIT FOR VENOUS CATHETER. This device is classified as a Wound Dressing Kit (Class II - Special Controls, product code MCY).
Submitted by Medi-Flex Hospital Products, Inc. (Overland Park, US). The FDA issued a Cleared decision on January 8, 1993, 296 days after receiving the submission on March 18, 1992.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 880.5075. This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. 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 | K921347 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - De Novo Granted (SEKD) |
| Date Received | March 18, 1992 |
| Decision Date | January 08, 1993 |
| Days to Decision | 296 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | MCY — Wound Dressing Kit |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5075 |
| Definition | This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. 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. |