Atlas FDA

FASTRAC GASTRIC ACCESS PORT KIT

FDA 510(k) clearance K033562 · decided 2003-12-12

Clearance details

K-number
K033562
Device name
FASTRAC GASTRIC ACCESS PORT KIT
Applicant
C.R. Bard, Inc.
Decision
Substantially Equivalent
Date received
2003-11-12
Decision date
2003-12-12
Days to decision
30 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

+ Add to Predicate Builder ◉ Watch C.R. Bard

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

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

RecordFirmDate
Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore Esophageal-Nasogastric Tube - 20 French (0092100); Blakemore Esophageal-Nasogastric Tube - 16 French (0092300) (K253514)C.R. Bard, Inc.2026-07-10
XNY Disposable Gastric Calibration Tube (K250389)Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd2025-04-10
Flexi-Seal AIR (with ENFit Connector) (K243228)Convatec2025-03-28
hygh-tec Drainage II (K242336)Amb Medtec2025-01-17
ZZIREN™ Orogastric Tube; ZZIREN™ SGT Orogastric Tube - 32 Fr (ZZ-SGT-32); ZZIREN™ SGT Orogastric Tube - 36 Fr (ZZ-SGT-36); ZZIREN™ SGT Orogastric Tube - 40 Fr (ZZ-SGT-40); ZZIREN™ GBT Orogastric Tube - 32 Fr (ZZ-GBT-32); ZZIREN™ GBT Orogastric Tube - 36 Fr (ZZ-GBT-36); ZZIREN™ GBT Orogastric Tube - 40 Fr (ZZ-GBT-40) (K242901)Tools For Surgery, LLC2025-01-10
Entarik NI Feeding Tube System (K241169)Gravitas Medical, Inc.2024-11-22
CORGRIP* SR NG/NI Tube Retention System (K241185)Avanos Medical, Inc.2024-10-25
CORTRAK* 2 Enteral Access System (20-0950) (K240965)Avanos Medical, Inc.2024-06-06
Stylus (K233591)Degania Silicone , Ltd.2024-05-31
ReShape Calibration Tubes (B-2032, B-2036, B-2040); ReShape Calibration Tubes (B-2017); Gastric Balloon Suction Catheter (B-2020) (K241039)Reshape Lifesciences2024-05-16
ViSiGi LUX (5332); ViSiGi LUX (5336); ViSiGi LUX (5340) (K234033)Boehringer Laboratories, LLC2024-05-06
Enteral Feeding Sets (K240039)Hangzhou Primecare Medical Co., Ltd.2024-04-17

Recalls involving this device

RecordFirmDate
Bard Access Systems, Inc., Gauderer Genie* II PEG (Percutaneous Endoscopic Gastrostomy) Sa recall (Z-2179-2009)C.R. Bard Access Systems, Inc2009-09-15
Bard Access Systems, Inc., Gauderer Genie* II PEG (Percutaneous Endoscopic Gastrostomy) Sa recall (Z-2180-2009)C.R. Bard Access Systems, Inc2009-09-15
Bard Access Systems, Inc., Ponsky* PEG (Percutaneous Endoscopic Gastrostomy) Safety System recall (Z-2181-2009)C.R. Bard Access Systems, Inc2009-09-15
Bard Access Systems, Inc., Ponsky* PEG (Percutaneous Endoscopic Gastrostomy) Safety System recall (Z-2182-2009)C.R. Bard Access Systems, Inc2009-09-15
Bard Access Systems, Inc., Bard* PEG (Percutaneous Endoscopic Gastrostomy) Safety System - recall (Z-2183-2009)C.R. Bard Access Systems, Inc2009-09-15
Bard Access Systems, Inc., FASTRAC "Pull" Gastric Access Port Kit, REF 005729, 20F, Steril recall (Z-2184-2009)C.R. Bard Access Systems, Inc2009-09-15
Bard Access Systems, Inc., FASTRAC* "Pull" Gastric Access Port Safety System, REF 006033, recall (Z-2185-2009)C.R. Bard Access Systems, Inc2009-09-15
Bard Access Systems, Inc., FASTRAC* Guidewire Gastric Access Port Safety System, REF 00603 recall (Z-2186-2009)C.R. Bard Access Systems, Inc2009-09-15
Bard Access Systems, Inc., Ponsky* PEG (Percutaneous Endoscopic Gastrostomy) Safety System recall (Z-2187-2009)C.R. Bard Access Systems, Inc2009-09-15
Bard Access Systems, Inc., Fastrac* "Pull" Gastric Access Port Safety System, REF 007023, recall (Z-2188-2009)C.R. Bard Access Systems, Inc2009-09-15
Bard Access Systems, Inc., Fastrac* Guidewire Gastric Access Port Safety System, REF 00702 recall (Z-2189-2009)C.R. Bard Access Systems, Inc2009-09-15
Bard Access Systems, Inc., Fastrac* Guidewire Gastric Access Port Safety System, REF 00703 recall (Z-2190-2009)C.R. Bard Access Systems, Inc2009-09-15
Bard Access Systems, Inc., Fastrac* Guidewire Gastric Access Port Safety System, REF 00703 recall (Z-2191-2009)C.R. Bard Access Systems, Inc2009-09-15
Bard Access Systems, Inc., Fastrac* "Pull" Gastric Access Port Kit, REF 007036, 24F, Steri recall (Z-2192-2009)C.R. Bard Access Systems, Inc2009-09-15
Bard Access Systems, Inc., Fastrac* "Pull" Gastric Access Port Kit, REF 007037, 16F, Steri recall (Z-2193-2009)C.R. Bard Access Systems, Inc2009-09-15
Bard Access Systems, Inc., Fastrac* "Pull" Gastric Access Port Kit, REF 007038, 14F, Steri recall (Z-2194-2009)C.R. Bard Access Systems, Inc2009-09-15
Bard Access Systems, Inc., Fastrac* "Pull" Gastric Access Port Kit, REF 007050, 24F, Steri recall (Z-2195-2009)C.R. Bard Access Systems, Inc2009-09-15
Bard Access Systems, Inc., Fastrac* "Pull" Gastric Access Port Safety System, REF 007052, recall (Z-2196-2009)C.R. Bard Access Systems, Inc2009-09-15
Bard Access Systems, Inc., Fastrac* "Pull" Gastric Access Port Safety System, REF 007056, recall (Z-2197-2009)C.R. Bard Access Systems, Inc2009-09-15
Bard Access Systems, Inc., Fastrac* "Pull" Gastric Access Port Kit, REF 007078, 20F, Steri recall (Z-2198-2009)C.R. Bard Access Systems, Inc2009-09-15
Bard Access Systems, Inc., Fastrac* Guidewire Gastric Access Port Kit, REF 007082, 20F, St recall (Z-2199-2009)C.R. Bard Access Systems, Inc2009-09-15
Bard Access Systems, Inc., Ponsky* Deluxe "Pull" PEG (Percutaneous Endoscopic Gastrostomy) recall (Z-2200-2009)C.R. Bard Access Systems, Inc2009-09-15
Bard Access Systems, Inc., Bard* Deluxe Guidewire PEG (Percutaneous Endoscopic Gastrostomy recall (Z-2201-2009)C.R. Bard Access Systems, Inc2009-09-15
Bard Access Systems, Inc., Ponsky* Deluxe "Pull" PEG (Percutaneous Endoscopic Gastrostomy) recall (Z-2202-2009)C.R. Bard Access Systems, Inc2009-09-15
Bard Access Systems, Inc., Bard* Deluxe Guidewire PEG (Percutaneous Endoscopic Gastrostomy recall (Z-2203-2009)C.R. Bard Access Systems, Inc2009-09-15
Bard Access Systems, Inc., Ponsky* PEG (Percutaneous Endoscopic Gastrostomy) Safety System recall (Z-2204-2009)C.R. Bard Access Systems, Inc2009-09-15
Bard Access Systems, Inc., Bard* PEG (Percutaneous Endoscopic Gastrostomy) Safety System - recall (Z-2205-2009)C.R. Bard Access Systems, Inc2009-09-15
Bard Access Systems, Inc., FASTRAC Guidewire Gastric Access Port Kit, REF 005739, 20F, Ste recall (Z-2206-2009)C.R. Bard Access Systems, Inc2009-09-15
Bard Access Systems, Inc., Bard* PEG (Percutaneous Endoscopic Gastrostomy) Safety System - recall (Z-2207-2009)C.R. Bard Access Systems, Inc2009-09-15

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