I.V. Start Set
FDA 510(k) K791885 · Ascep, Inc.
510(k) numberK791885
Submission
- Device name
- I.V. Start Set
- Applicant
- Ascep, Inc.
Mchenry, IL, US - Received
- September 11, 1979
- Decision date
- October 22, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KGX – Tape And Bandage, Adhesive
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.5240
- Specialty
- General Hospital
Other 510(k)s with product code KGX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K001240 | Seragard Injection PatchKGX · Traditional | Platinum Services, Inc. | 06/21/2000SE |
| K983368 | Care Band Antibacterial BandagesKGX · Traditional | Aso Corp. | 02/17/1999SE |
| K972914 | Syvek PatchKGX · Traditional | Marine Polymer Technologies, Inc. | 12/22/1997SE |
| K943314 | Adhesive Bandages with OTC DrugKGX · Traditional | Johnson & Johnson Consumer Products, Inc. | 01/17/1996SE |
| K952606 | Targett PatchKGX · Traditional | Cutting Edge Technologies, Inc. | 12/21/1995SE |
| K954007 | ParallelKGX · Traditional | Johnson & Johnson Consumer Products, Inc. | 11/22/1995SE |
| K944587 | Dermiview Hypoallergenic Clear TapeKGX · Traditional | Johnson & Johnson Medical, Inc. | 10/30/1995SE |
| K944588 | Sterile Plastic DressingKGX · Traditional | Smith & Nephew, Inc. | 11/07/1994SE |
| K941788 | Band-Aid Brand Adhesive Bandages, Sport StripKGX · Traditional | Johnson & Johnson Consumer Products, Inc. | 10/03/1994SE |
| K940536 | Band-Aid(Tm) Brand Adhesive BandageKGX · Traditional | Johnson & Johnson Consumer Products, Inc. | 10/03/1994SE |
More from Johnson & Johnson Consumer Products, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K830219 | Various Instruments & Instrument TraysFSM · Traditional | 04/12/1983SE |
| K822893 | G.E.V. Disposable ScalpelsGDX · Traditional | 10/22/1982SE |
| K810004 | Sterile Disposable Instrument TraysFSM · Traditional | 01/26/1981SE |
| K802726 | Instruments Nonsterile & SterileHAO · Traditional | 11/19/1980SE |
| K791886 | I.V. Care KitKGX · Traditional | 10/26/1979SE |
| K791889 | Suture Removal Tray, Reorder 7950&7951FSM · Traditional | 10/17/1979SE |
| K791888 | Catheter Care Kit Reorder 7940&7941EFQ · Traditional | 10/17/1979SE |
| K791887 | Central Venous Catheter Dressing TrayFSM · Traditional | 10/17/1979SE |
Questions and answers
When was I.V. Start Set cleared by the FDA?
I.V. Start Set (K791885) received a 510(k) decision of Substantially Equivalent on October 22, 1979, 41 days after the submission was received.
What is the product code of K791885?
The FDA product code is KGX – Tape And Bandage, Adhesive, a Class I (low risk) device regulated under 21 CFR 880.5240.