Drainovac Complete Closed Wound Drainage Device
FDA 510(k) K863482 · Cardio Metrics, Inc.
510(k) numberK863482
Submission
- Device name
- Drainovac Complete Closed Wound Drainage Device
- Applicant
- Cardio Metrics, Inc.
Houston, TX, US - Received
- September 9, 1986
- Decision date
- October 14, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GCY – Apparatus, Suction, Single Patient Use, Portable, Nonpowered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4680
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code GCY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K972703 | Redyrob-Closed Wound Drainage SystemGCY · Traditional | B.Braun Medical, Inc. | 10/01/1997SE |
| K971036 | Odontit Autogenous Bone Collection DeviceGCY · Traditional | Interpore Intl. | 06/03/1997SE |
| K963839 | Cordis Suction Reservoir - Model Number: 910-500GCY · Traditional | Cordis Corp. | 12/12/1996SE |
| K960099 | Penrose Drain Models 6001 - 6007GCY · Traditional | Sil-Med Corp. | 03/11/1996SE |
| K950754 | Macro Suction Tube Model No 10061GCY · Traditional | Dlp, Inc. | 04/25/1995SE |
| K936223 | Pressure Irrigating SystemGCY · Traditional | Level 1 Technologies, Inc. | 05/12/1994SE |
| K930615 | Autovac Closed Wound Suction SystemGCY · Traditional | Boehringer Laboratories | 02/22/1994SE |
| K933319 | Birtcher GS-9480 Integrated 3-CHIP Camera/Xenon Light Source Visualization SystemGCY · Traditional | Birtcher Medical Systems, Inc. | 10/27/1993SE |
| K933306 | Imc 5.0MM Irrigation/Aspiration Probe W/HolesGCY · Traditional | Inman Medical Corp. | 10/05/1993SE |
| K933305 | Imc 5.0MM Irrigation/Aspiration ProbeGCY · Traditional | Inman Medical Corp. | 10/05/1993SE |
More from Inman Medical Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K972762 | Cardiometrics Flowire 300 and XT 300 Doppler Guide WiresDQX · Traditional | 10/14/1997SE |
| K965140 | Cardiometrics Wavewire/Wavemap Pressure SystemDQX · Traditional | 08/18/1997SE |
| K951567 | Cardiometics Flowire, Smartwire Doppler Guide WireITX · Traditional | 10/25/1996SE |
| K961777 | Accutrac XT Intravascular Guide Wire (Floppy) Model 2403/(FLEX) Model 2404DQX · Traditional | 07/31/1996SE |
| K955551 | CARDI0METRICS Flow Wire XT Doppler Guide Model 1403, 1404DQX · Traditional | 02/28/1996SE |
| K954913 | Cardiometrics Accutrac Intravascular Guide Wire (Modification)DQX · Traditional | 11/07/1995SE |
| K952562 | Cardiometrics Accutrac Intravascular Guide WireDQX · Traditional | 08/29/1995SE |
| K943022 | Cardiometrics Flowire Doppler Guide WireDQX · Traditional | 09/19/1994SE |
| K940984 | Cardiometrics Dualflow Switch BoxDQX · Traditional | 08/18/1994SE |
| K933320 | Cardiometrics Flomap and Flomod Ultrasound InstrumentIYO · Traditional | 08/17/1994SE |
Questions and answers
When was Drainovac Complete Closed Wound Drainage Device cleared by the FDA?
Drainovac Complete Closed Wound Drainage Device (K863482) received a 510(k) decision of Substantially Equivalent on October 14, 1986, 35 days after the submission was received.
What is the product code of K863482?
The FDA product code is GCY – Apparatus, Suction, Single Patient Use, Portable, Nonpowered, a Class I (low risk) device regulated under 21 CFR 878.4680.