Air Aspirator Needle
FDA 510(k) K801393 · Texas Medical Products, Inc.
510(k) numberK801393
Submission
- Device name
- Air Aspirator Needle
- Applicant
- Texas Medical Products, Inc.
Walker, MI, US - Received
- June 13, 1980
- Decision date
- June 30, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DWS – Instruments, Surgical, Cardiovascular
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 870.4500
- Specialty
- Cardiovascular
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|---|---|---|---|
| K022238 | Myocardial Lead Implant Tool, Model 10626DWS · Traditional | Medtronic Vascular | 10/09/2002SE |
| K964445 | Octopus Tissue Stabilizer (28001/28002/28003/28004/28005/28006)DWS · Traditional | Dlp, Inc. | 01/30/1997SE |
| K962771 | Burke Congenital Thoracoscopy InstrumentsDWS · Traditional | Pilling Weck, Inc. | 11/19/1996SE |
| K955689 | RNS Sterile, Disposable Digital Angiographic TrayDWS · Traditional | Contour Fabricators of Florida, Inc. | 05/15/1996SE |
| K960139 | G.E. Sterile Angiographic TrayDWS · Traditional | GE Medical Systems | 04/19/1996SESK |
| K960144 | G.E. Sterile CT Biopsy TrayDWS · Traditional | GE Medical Systems | 04/15/1996SESK |
| K960143 | G.E. Sterile Digital Angiographic TrayDWS · Traditional | GE Medical Systems | 04/09/1996SESK |
| K934727 | Replacement Parts for Cpi 6888 Lead TunnelerDWS · Traditional | Cardiac Pacemakers, Inc. | 01/10/1994SE |
| K900379 | Hycult Diamond Coronary Bypass KnifeDWS · Traditional | St. Jude Medical, Inc. | 03/19/1990SE |
| K896307 | Insulation PadDWS · Traditional | Bio-Vascular, Inc. | 01/19/1990SE |
More from Bio-Vascular, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K893417 | Surgifresh Sub-Micron Mask No. 901008-000FXX · Traditional | 06/22/1989SE |
| K870932 | Surgifresh Surgical Smoke Removal · Traditional | 03/31/1987SE |
| K851575 | Dr. Bruno Lnage Mini Photometer · Traditional | 10/18/1985SE |
| K830634 | Cardiotomy FilterJOD · Traditional | 06/30/1983SE |
| K813587 | Disposable Thoracic CatheterGBS · Traditional | 01/12/1982SE |
| K810532 | Disposable StopcockDTZ · Traditional | 04/23/1981SE |
| K810515 | Disposable 2-STAGE CannulaDWF · Traditional | 04/23/1981SE |
| K810395 | Pre-Bypass FilterKRJ · Traditional | 03/05/1981SE |
| K802545 | Cardioplegic SetsDTR · Traditional | 01/16/1981SE |
| K802544 | Disposable Quick Release Perfusion AdapDTL · Traditional | 01/16/1981SE |
Questions and answers
When was Air Aspirator Needle cleared by the FDA?
Air Aspirator Needle (K801393) received a 510(k) decision of Substantially Equivalent on June 30, 1980, 17 days after the submission was received.
What is the product code of K801393?
The FDA product code is DWS – Instruments, Surgical, Cardiovascular, a Class I (low risk) device regulated under 21 CFR 870.4500.