Atlas FDA

DUAL PORT WIZARD LOW PROFILE REPLACEMENT GASTROSTOMY DEVICE; DUAL PORT WIZARD FEEDING/DECOMPRESSION TUBE, MODEL 00220W

FDA 510(k) clearance K013144 · decided 2001-10-19

Clearance details

K-number
K013144
Device name
DUAL PORT WIZARD LOW PROFILE REPLACEMENT GASTROSTOMY DEVICE; DUAL PORT WIZARD FEEDING/DECOMPRESSION TUBE, MODEL 00220W
Applicant
C.R. Bard, Inc.
Decision
Substantially Equivalent
Date received
2001-09-20
Decision date
2001-10-19
Days to decision
29 days
Clearance type
Special
Product code
KNT
Device class
2
Regulation number
876.5980
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Billerica, MA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00200W, 16F x 1.2cm, 10cc recall (Z-1096-2009)C R Bard Inc2009-04-08
Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00201W, 16F x 1.7cm, 10cc recall (Z-1097-2009)C R Bard Inc2009-04-08
Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00202W, 16F x 2.4cm, 10cc recall (Z-1098-2009)C R Bard Inc2009-04-08
Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00203W, 20F x 1.2cm, 10cc recall (Z-1099-2009)C R Bard Inc2009-04-08
Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00204W, 20F x 1.7cm, 10cc recall (Z-1100-2009)C R Bard Inc2009-04-08
Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00205W, 20F x 2.4cm, 10cc recall (Z-1101-2009)C R Bard Inc2009-04-08
Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00206W, 20F x 3.4cm, 10cc recall (Z-1102-2009)C R Bard Inc2009-04-08
Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00207W, 20F x 4.4cm, 10cc recall (Z-1103-2009)C R Bard Inc2009-04-08
Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00210, 16F x 2.4cm, 20cc, recall (Z-1104-2009)C R Bard Inc2009-04-08
Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00212W, 20F x 1.7cm, 20cc recall (Z-1105-2009)C R Bard Inc2009-04-08
Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00213W, 20F x 2.4cm, 20cc recall (Z-1106-2009)C R Bard Inc2009-04-08
Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00214W, 20F x 3.4cm, 20cc recall (Z-1107-2009)C R Bard Inc2009-04-08
Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00215W, 20F x 4.4cm, 20cc recall (Z-1108-2009)C R Bard Inc2009-04-08
Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00216W, 24F x 1.7cm, 20cc recall (Z-1109-2009)C R Bard Inc2009-04-08
Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00217W, 24F x 2.4cm, 20cc recall (Z-1110-2009)C R Bard Inc2009-04-08
Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00218W, 24F x 3.4cm, 20cc recall (Z-1111-2009)C R Bard Inc2009-04-08
Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00219W, 24F x 4.4cm, 20cc recall (Z-1112-2009)C R Bard Inc2009-04-08
Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00221W, 18F x 1.2cm, 10cc recall (Z-1113-2009)C R Bard Inc2009-04-08
Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00222W, 18F x 1.7cm, 10cc recall (Z-1114-2009)C R Bard Inc2009-04-08
Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00223W, 18F x 2.4cm, 10cc recall (Z-1115-2009)C R Bard Inc2009-04-08
Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00224W, 18F x 3.4cm, 10cc recall (Z-1116-2009)C R Bard Inc2009-04-08
Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00225W, 18F x 4.4cm, 10cc recall (Z-1117-2009)C R Bard Inc2009-04-08
Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00200W, 16F, 1.2cm, 10cc recall (Z-0416-2009)C R Bard Inc2008-12-12
Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00201W, 16F, 1.7cm, 10cc recall (Z-0417-2009)C R Bard Inc2008-12-12
Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00202W, 16F, 2.4cm, 10cc recall (Z-0418-2009)C R Bard Inc2008-12-12
Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00203W, 20F, 1.2cm, 10cc recall (Z-0419-2009)C R Bard Inc2008-12-12
Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00204W, 20F, 1.7cm, 10cc recall (Z-0420-2009)C R Bard Inc2008-12-12
Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00205W, 20F, 2.4cm, 10cc recall (Z-0421-2009)C R Bard Inc2008-12-12
Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00206W, 20F, 3.4cm, 10cc recall (Z-0422-2009)C R Bard Inc2008-12-12
Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00207W, 20F, 4.4cm, 10cc recall (Z-0423-2009)C R Bard Inc2008-12-12
Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00209W, 16F, 1.7cm, 20cc recall (Z-0424-2009)C R Bard Inc2008-12-12
Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00210W, 16F, 2.4cm, 20cc recall (Z-0425-2009)C R Bard Inc2008-12-12
Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00212W, 20F, 1.7cm, 20cc recall (Z-0426-2009)C R Bard Inc2008-12-12
Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00213W, 20F, 2.4cm, 20cc recall (Z-0427-2009)C R Bard Inc2008-12-12
Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00214W, 20F, 3.4cm, 20cc recall (Z-0428-2009)C R Bard Inc2008-12-12
Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00215W, 20F, 4.4cm, 20cc recall (Z-0429-2009)C R Bard Inc2008-12-12
Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00216W, 24F, 1.7cm, 20cc recall (Z-0430-2009)C R Bard Inc2008-12-12
Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00217W, 24F, 2.4cm, 20cc recall (Z-0431-2009)C R Bard Inc2008-12-12
Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00218W, 24F, 3.4cm, 20cc recall (Z-0432-2009)C R Bard Inc2008-12-12
Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00219W, 24F, 4.4cm, 20cc recall (Z-0433-2009)C R Bard Inc2008-12-12
Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00221W, 18F, 1.2cm, 10cc recall (Z-0434-2009)C R Bard Inc2008-12-12
Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00222W, 18F, 1.7cm, 10cc recall (Z-0435-2009)C R Bard Inc2008-12-12
Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00223W, 18F, 2.4cm, 10cc recall (Z-0436-2009)C R Bard Inc2008-12-12
Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00224W, 18F, 3.4cm, 10cc recall (Z-0437-2009)C R Bard Inc2008-12-12
Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00225W, 18F, 4.4cm, 10cc recall (Z-0438-2009)C R Bard Inc2008-12-12

PMA approvals by this applicant

RecordFirmDate
Covera™ Vascular Covered Stent (P170042/S014)C.R. Bard, Inc.2025-12-16
Covera™ Vascular Covered Stents (P170042/S013)C.R. Bard, Inc.2025-06-26
Avitene Microfibrillar Collagen Hemostat (P800002/S033)C.R. Bard, Inc.2025-03-13
AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT NON-WOVEN WEB (P800002/S032)C.R. Bard, Inc.2025-02-18
Avitene™ Bulk Flour Cleanroom Expansion (P800002/S031)C.R. Bard, Inc.2024-01-18
Avitene™ Microfibrillar Collagen Hemostat (P800002/S030)C.R. Bard, Inc.2023-10-04
Covera™ Vascular Covered Stent (P170042/S012)C.R. Bard, Inc.2023-02-02
Avitene Microfibrillar Collagen Hemostat (MCH) Non-Woven Web and Avitene Microfibrillar Collagen Hemostat (MCH) EndoAvit (P800002/S027)C.R. Bard, Inc.2022-04-01