INTERVENT ALLERGEN EXCLUSION TECHNOLOGY, INTERVENT BEDDING SYSTEM, INTERVENT MATTRESS INTERLINER, INTERVIEW PILLOW
FDA 510(k) clearance K940327 · decided 1994-02-25
Clearance details
- K-number
- K940327
- Device name
- INTERVENT ALLERGEN EXCLUSION TECHNOLOGY, INTERVENT BEDDING SYSTEM, INTERVENT MATTRESS INTERLINER, INTERVIEW PILLOW
- Applicant
- W. L. Gore & Associates, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-01-24
- Decision date
- 1994-02-25
- Days to decision
- 32 days
- Clearance type
- Traditional
- Product code
- FMW
- Device class
- 1
- Regulation number
- 880.6190
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Flagstaff, AR, US
- Third-party review
- No
- Expedited review
- No
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| REUSABLE INCONTIENT UNDERPAD (K924807) | Perfect Fit Industries, Inc. | 1993-02-10 |
| WIPEABLE PILLOW (K924477) | Perfect Fit Industries, Inc. | 1993-01-29 |
| OBALON COVER (K923173) | Turnsoft, Inc. | 1992-11-06 |
| SOFT-COVER (K921928) | Adroit Medical Systems, Inc. | 1992-11-06 |
| ALLERGY CONTROL COVERS (K903382) | Allergy Control Products, Inc. | 1990-11-02 |
| DISPOSABLE STERILE TABLE TOP COVER FOR HYDRADJUST (K902446) | Mallinckrodt Group, Inc. | 1990-08-10 |
| MATTRESS COVER, ANTI-MICROBIAL (K832483) | American Threshold Industries, Inc. | 1984-02-04 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| GORE® VIABAHN® FORTEGRA Venous Stent (P250017) | W. L. Gore & Associates, Inc. | 2025-12-19 |
| GORE® CARDIOFORM Septal Occluder; GORE® CARDIOFORM ASD Occluder (P050006/S116) | W. L. Gore & Associates, Inc. | 2025-12-19 |
| GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (P160021/S048) | W. L. Gore & Associates, Inc. | 2025-11-24 |
| GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion (P040027/S099) | W. L. Gore & Associates, Inc. | 2025-10-27 |
| GORE® VIABAHN® Endoprosthesis and GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface (P130006/S110) | W. L. Gore & Associates, Inc. | 2025-10-17 |
| GORE® VIABAHN® Endoprosthesis; GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface (P040037/S171) | W. L. Gore & Associates, Inc. | 2025-10-17 |
| GORE® TAG® Thoracic Branch Endoprosthesis (P210032/S024) | W. L. Gore & Associates, Inc. | 2025-10-17 |
| GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (P160021/S049) | W. L. Gore & Associates, Inc. | 2025-10-17 |