Collagen Shield for Acute Care
FDA 510(k) K913148 · Vitaphore Corp.
510(k) numberK913148
Submission
- Device name
- Collagen Shield for Acute Care
- Applicant
- Vitaphore Corp.
Menlo Park, CA, US - Received
- July 16, 1991
- Decision date
- October 15, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MOE – Collagen Corneal Shield
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.4750
- Specialty
- Ophthalmic
Other 510(k)s with product code MOE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K944872 | Bio-Cor Collagen Corneal ShieldMOE · Traditional | Bausch & Lomb Healthcare and Optics Worldwide | 07/26/1995SE |
| K915861 | Medilens-Cs Corneal ShieldMOE · Traditional | Chiron Ophthalmics | 03/06/1992SE |
| K914529 | Softshield(Tm) 12, 24, 72 Collagen Corneal ShieldsMOE · Traditional | Oasis Medical, Inc. | 11/13/1991SE |
| K905825 | Collagen Shield, Various ModelsMOE · Traditional | Chiron Ophthalmics | 06/10/1991SE |
| K902558 | Collagen Shield for Acute CareMOE · Traditional | Vitaphore Corp. | 08/17/1990SE |
| K901880 | Medilens(Tm) Corneal ShieldMOE · Traditional | Chiron Ophthalmics | 07/02/1990SE |
| K896449 | Im Collagen ShieldMOE · Traditional | Intermedical, Inc. | 05/24/1990SE |
| K884962 | Addit. Indications for Bio-Cor Ext Collagen CorneaMOE · Traditional | Bausch & Lomb Pharmaceutical, Inc. | 02/09/1990SE |
| K885015 | Coi 72 HR Collagen ShieldMOE · Traditional | Chiron Ophthalmics | 06/23/1989SE |
| K884961 | Addit. Indications for Bio-Cor II Collagen CornealMOE · Traditional | Bausch & Lomb Pharmaceutical, Inc. | 02/13/1989SE |
More from Bausch & Lomb Pharmaceutical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K914579 | Silver Foam Wound DressingFRO · Traditional | 02/21/1992SE |
| K895920 | Vitapatch Pin Protection Device for PercutaneousKGX · Traditional | 06/06/1991SE |
| 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 Collagen Shield for Acute Care cleared by the FDA?
Collagen Shield for Acute Care (K913148) received a 510(k) decision of Substantially Equivalent on October 15, 1991, 91 days after the submission was received.
What is the product code of K913148?
The FDA product code is MOE – Collagen Corneal Shield, a Class I (low risk) device regulated under 21 CFR 886.4750.