510(k) K811378
- Device
- PERCUTANEOUS DRAINING CATHETER
- Applicant
- MEDI-TECH, INC.
- 510(k) number
- K811378
- Product code
- GBW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1981-06-02
- Date received
- 1981-05-15
- Regulation
- 878.4200
- Classification name
- Catheter, Peritoneal
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 4221 Richmond Rd., NW Walker MI US 49534 49534
FDA Registration Numbers#
- 1018470
- 1423537
- 3018167761
- 3004134316
- 3003965134
- 1828132
- 3003898360
- 1646747
- 9611665
- 1836161
- 1043214
- 3015309643
- 3006950086
- 1320894
- 2529647
- 3010400865
- 3010452421
- 3003502083
- 3033589330
- 3003903031
- 2124215
- 8022978
- 1055236
- 3007092328
- 3007305485
- 3004111573
- 1721676
- 3003733874
- 3002303166
- 9680794
- 1825146
- 3004491689
- 9612126
- 1721504
- 1420054
- 9611088
- 1724474
- 8030607
- 9616088
- 3027977504
- 2433012
- 3010131137
- 1820334
- 3015225571
- 3011137372
- 3012494290
- 3015859709
- 3012536737
- 3013557562
- 3012706378
- 1054241
- 1061124
- 3004859241
- 1928237
- 3010041511
- 3003915875
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GBW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K992907 | INTRADUCER | Taut, Inc. | 1999-10-05 |
| K992904 | MINI-PORT | Taut, Inc. | 1999-10-05 |
| K972112 | INTRADUCER PORT SC CATALOG#31275,31035,30915, AND 31450 | Taut, Inc. | 1997-12-01 |
| K961194 | ANTIMICROBIAL MEDIASTINAL SILICONE DRAIN | Sil-Med Corp. | 1996-08-08 |
| K960426 | MEDICOMP FLEXI-SMOOTH WOUND DRAINAGE CATHETER | Medical Components, Inc. | 1996-03-21 |
| K942709 | MEDIASTINAL SILICONE DRAINS | Sil-Med Corp. | 1996-01-04 |
| K933510 | ARGYLE TURKEL SAFETY TROCAR THORACIC CATHETER | Sherwood Medical Co. | 1994-02-24 |
| K926477 | BIFURCATED SUCTION/IRRIGAT TUBING SET W/PUSH BUTTO | Core Dynamics, Inc. | 1993-11-12 |
| K913733 | STERILE CHEST TUBE | Vascular Products, Inc. | 1991-10-08 |
| K894220 | HOUTS HYSTERECTOMY DRAIN | Helix Medical, Inc. | 1989-08-24 |
| K894119 | MADEGOM LTDA. PENROSE DRAIN TUBING | Madegom | 1989-08-18 |
| K854812 | NELSON-JUNG PLEURAL CATH | Research Medical, Inc. | 1986-02-11 |
| K843575 | DERBYSHIRE DRAIN | Sil-Med Corp. | 1984-10-24 |
| K813063 | FLAT DRAIN | Sil-Med Corp. | 1981-12-18 |
| K811627 | ARROW PERITONEAL LAVAGE CATHERIZATION K | Arrow Intl., Inc. | 1981-08-10 |
Legacy Summary#
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FDA Review#
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