Cepti-Seal Dressing Change Kit for Venous Catheter
FDA 510(k) K921347 · Medi-Flex Hospital Products, Inc.
510(k) numberK921347
Submission
- Device name
- Cepti-Seal Dressing Change Kit for Venous Catheter
- Applicant
- Medi-Flex Hospital Products, Inc.
Overland Park, KS, US - Received
- March 18, 1992
- Decision date
- January 8, 1993
- Decision
- Unknown (SEKD)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- MCY – Wound Dressing Kit
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5075
- Specialty
- General Hospital
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.
Other 510(k)s with product code MCY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K970721 | Dyna-Flex Multi-Layer Compression SystemMCY · Traditional | Johnson & Johnson Medical, Inc. | 03/21/1997SN |
| K963719 | Central Line Dressing Change Tray, Tpn/Cvp Dressing Change TrayMCY · Traditional | Grand Medical Products | 11/27/1996SE |
| K960585 | Wound Care Compression System (WCCS)MCY · Traditional | Suncoast Medical Products, Inc. | 04/26/1996SE |
| K952334 | Dressing Change TrayMCY · Traditional | Busse Hospital Disposables, Inc. | 07/14/1995SE |
| K951022 | Circulon System Step 1MCY · Traditional | Convatec, A Division of E.R. Squibb & Sons | 06/12/1995SESK |
| K951021 | Circulon System Step 2MCY · Traditional | Convatec, A Division of E.R. Squibb & Sons | 06/12/1995SESK |
| K951476 | E-Pack Procedure KitsMCY · Traditional | ETHICON, Inc. | 05/23/1995SESK |
| K931932 | Dressing Change Tray-ModifiedMCY · Traditional | Medsurg Industries, Inc. | 08/27/1993SEKD |
| K924690 | Various Non-Sterile Custom Trays/KitsMCY · Traditional | Surgipro Central, Inc. | 07/16/1993SEKD |
| K923905 | Wound Dressing KitMCY · Traditional | Kit Pak, Inc. | 07/02/1993SEKD |
More from Kit Pak, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K970441 | K-Klosure 2 Inch LENGTH/4 Inch LENGTH/8 Inch LENGTH/12 Inch LengthFPX · Traditional | 05/09/1997SE |
| K962740 | Dermistick Sepp APPLICATOR(200 CT)/(40 CT) 260640/260641KMF · Traditional | 09/06/1996SE |
| K952201 | Port-A-Cath Access KitFMF · Traditional | 10/04/1995SE |
| K952416 | Tracheostomy Care KitBTO · Traditional | 08/09/1995SESK |
| K952256 | Picc Line KitFOZ · Traditional | 07/31/1995SE |
| K952007 | Adherol Sepp ApplicatorFRO · Traditional | 06/08/1995SE |
| K934790 | Sepp Adhesive RemoverKOX · Traditional | 03/11/1994SE |
| K923516 | Compound Benzoin Tincture Usp SeppKMF · Traditional | 01/25/1994SE |
| K920399 | Compound Benzoin Tincture Usp FreppKMF · Traditional | 01/25/1994SE |
| K930196 | Cepti-Seal I.V. Prep KitLRS · Traditional | 07/02/1993SEKD |
Questions and answers
When was Cepti-Seal Dressing Change Kit for Venous Catheter cleared by the FDA?
Cepti-Seal Dressing Change Kit for Venous Catheter (K921347) received a 510(k) decision of Unknown on January 8, 1993, 296 days after the submission was received.
What is the product code of K921347?
The FDA product code is MCY – Wound Dressing Kit, a Class II (moderate risk) device regulated under 21 CFR 880.5075.