Vitapatch Pin Protection Device for Percutaneous
FDA 510(k) K895920 · Vitaphore Corp.
510(k) numberK895920
Submission
- Device name
- Vitapatch Pin Protection Device for Percutaneous
- Applicant
- Vitaphore Corp.
Menlo Park, CA, US - Received
- October 11, 1989
- Decision date
- June 6, 1991
- 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 |
|---|---|---|
| K914579 | Silver Foam Wound DressingFRO · Traditional | 02/21/1992SE |
| K913148 | Collagen Shield for Acute CareMOE · Traditional | 10/15/1991SE |
| K902558 | Collagen Shield for Acute CareMOE · Traditional | 08/17/1990SE |
| K891993 | Collagen NeurospongeHBA · Traditional | 03/23/1990SE |
| K896455 | Vitachoice Wound DressingKGX · Traditional | 02/15/1990SE |
| K896046 | Vitapatch Cath. Securement Device W/ChlorhexidineKMK · Traditional | 01/11/1990SE |
| K895993 | Vitapatch Antimicrobial Catheter Securement DeviceKMK · Traditional | 01/11/1990SE |
| K890435 | Vitaaccess Catheter Introducer KitFOZ · Traditional | 03/29/1989SESD |
| K882100 | Vitacuff(R) Percutaneous Infect. Control KitLJS · Traditional | 07/13/1988SE |
| K872998 | Vitaaccess (TM) Catheter Introducer SystemFOZ · Traditional | 03/24/1988SE |
Questions and answers
When was Vitapatch Pin Protection Device for Percutaneous cleared by the FDA?
Vitapatch Pin Protection Device for Percutaneous (K895920) received a 510(k) decision of Substantially Equivalent on June 6, 1991, 603 days after the submission was received.
What is the product code of K895920?
The FDA product code is KGX – Tape And Bandage, Adhesive, a Class I (low risk) device regulated under 21 CFR 880.5240.