Atlas FDA

PROMEON HYDROGEL DRESSING #45 STERILE W/ MESH

FDA 510(k) clearance K915359 · decided 1992-05-28

Clearance details

K-number
K915359
Device name
PROMEON HYDROGEL DRESSING #45 STERILE W/ MESH
Applicant
Medtronic Vascular
Decision
Substantially Equivalent
Date received
1991-11-27
Decision date
1992-05-28
Days to decision
183 days
Clearance type
Traditional
Product code
NAE
Device class
1
Regulation number
878.4022
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
Brooklyn Center, MN, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
MODIFICATION TO ZENIEVA (K083721)River'S Edge Pharmaceuticals, LLC2009-01-08
MODIFICATION TO ZENIEVA (K082865)Gorbec Pharmaceutical Services, Inc.2008-10-23
ZENIEVA (K073246)Gorbec Pharmaceutical Services, Inc.2008-07-23
GILTECH PLUS HYDROGEL SKIN DRESSING (K992094)Giltech Plus, Inc.1999-09-17
DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING (K991061)Dermaphylyx, Inc.1999-06-28
AD-HEAL HYDROGEL DRESSING, VARIOUS SIZES (K972646)Ludlow Technical Products1997-08-21
COMFEEL PURILON GEL,15G(3900)/COMFEEL PURILON GEL,25G(3903) (K971597)Coloplast Corp.1997-07-29
HYDROGEL SKIN DRESSING (K962352)North American Sterilization & Packaging Co.1996-08-02
AQUAFLO HYDROGEL WOUND DRESSING & PACKER (K952945)Sherwood Medical Co.1995-08-23
BIODERM MEDICAL HYDROGEL ISLAND DRESSING (K951166)Bioderm, Inc.1995-06-21
CURAGEL HYDROGEL WOUND DRESSING (K950412)Kendall Healthcare Products Co. Div.Of Tyco Health1995-03-24
BRADY MEDICAL PRODUCTS TRANSCORBENT AND THINSITE TOPICAL BORDER WOUND DRESSINGS (K945832)Brady Medical Products Co.1995-03-01

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
Resolute Onyx Zotarolimus-Eluting Coronary Stent System - RX and OTW; Onyx Frontier Zotarolimus-Eluting Coronary Stent S (P160043/S089)Medtronic Vascular2025-12-19
Endurant II/IIs Stent Graft System (P100021/S131)Medtronic Vascular2025-10-23
Endurant Stent Graft System, Endurant II Stent Graft System, Endurant IIs Stent Graft System (P100021/S129)Medtronic Vascular2025-09-15
Resolute Onyx (P160043/S088)Medtronic Vascular2025-06-26
Endurant Stent Graft System (P100021/S130)Medtronic Vascular2025-06-12
Valiant Thoracic Stent Graft with the Captivia Delivery System (P100040/S073)Medtronic Vascular2025-06-12
Valiant Thoracic Stent Graft with the Captivia Delivery System (P100040/S072)Medtronic Vascular2025-05-20
Valiant Thoracic Stent Graft with the Captiva Delivery System (P100040/S069)Medtronic Vascular2025-05-08