Catheter, Peritoneal
The Catheter, Peritoneal (product code GBW) is a catheter placed into the peritoneal cavity for drainage of ascitic fluid, delivery of dialysis solutions, or irrigation of the abdominal cavity during or after general surgery procedures. It is classified as FDA Class 1, the lowest risk tier, subject only to general controls and not requiring a premarket notification. The device is regulated under 21 CFR 878.4200 in the General, Plastic Surgery specialty (SU). No special flags apply to this device.
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Basic Information
- Product Code
- GBW
- Device Class
- FDA class 1
- Regulation Number
- 878.4200
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 17 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K992907 | INTRADUCER | Oct 05, 1999 | Substantially Equivalent | Taut, Inc. |
| K992904 | MINI-PORT | Oct 05, 1999 | Substantially Equivalent | Taut, Inc. |
| K972112 | INTRADUCER PORT SC CATALOG#31275,31035,30915, AND 31450 | Dec 01, 1997 | Substantially Equivalent | Taut, Inc. |
| K961194 | ANTIMICROBIAL MEDIASTINAL SILICONE DRAIN | Aug 08, 1996 | Substantially Equivalent | Sil-Med Corp. |
| K960426 | MEDICOMP FLEXI-SMOOTH WOUND DRAINAGE CATHETER | Mar 21, 1996 | Substantially Equivalent | Medical Components, Inc. |
| K942709 | MEDIASTINAL SILICONE DRAINS | Jan 04, 1996 | Substantially Equivalent for Some Indications | Sil-Med Corp. |
| K933510 | ARGYLE TURKEL SAFETY TROCAR THORACIC CATHETER | Feb 24, 1994 | Substantially Equivalent | Sherwood Medical Co. |
| K926477 | BIFURCATED SUCTION/IRRIGAT TUBING SET W/PUSH BUTTO | Nov 12, 1993 | Substantially Equivalent | Core Dynamics, Inc. |
| K913733 | STERILE CHEST TUBE | Oct 08, 1991 | Substantially Equivalent | Vascular Products, Inc. |
| K894220 | HOUTS HYSTERECTOMY DRAIN | Aug 24, 1989 | Substantially Equivalent | Helix Medical, Inc. |
| K894119 | MADEGOM LTDA. PENROSE DRAIN TUBING | Aug 18, 1989 | Substantially Equivalent | Madegom |
| K854812 | NELSON-JUNG PLEURAL CATH | Feb 11, 1986 | Substantially Equivalent | Research Medical, Inc. |
| K843575 | DERBYSHIRE DRAIN | Oct 24, 1984 | Substantially Equivalent | Sil-Med Corp. |
| K813063 | FLAT DRAIN | Dec 18, 1981 | Substantially Equivalent | Sil-Med Corp. |
| K811627 | ARROW PERITONEAL LAVAGE CATHERIZATION K | Aug 10, 1981 | Substantially Equivalent | Arrow Intl., Inc. |
| K811378 | PERCUTANEOUS DRAINING CATHETER | Jun 02, 1981 | Substantially Equivalent | Medi-Tech, Inc. |
| K800422 | ADT MINI PERITONEAL LAVAGE KIT | Mar 12, 1980 | Substantially Equivalent | A.D.T. Lab Industries |
FEI Numbers
This FDA classification entry is associated with 57 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 57 registration numbers. Click on an entry to view related FDA registrations.