Intersept* Oxygen Gas Line Filter
FDA 510(k) K882136 · Medtronic Blood Systems, Inc.
510(k) numberK882136
Submission
- Device name
- Intersept* Oxygen Gas Line Filter
- Applicant
- Medtronic Blood Systems, Inc.
Anaheim, CA, US - Received
- May 20, 1988
- Decision date
- August 11, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KRD – Device, Vascular, For Promoting Embolization
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.3300
- Specialty
- Cardiovascular
- Implant
- Yes
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| K261866 | Concerto Versa Detachable CoilKRD · Special | Medtronic, Inc. | 06/24/2026SE |
| K260635 | HARBOR Occlusion DeviceKRD · Traditional | Nuvascular, Inc. | 06/12/2026SE |
| K260508 | LOBO Vascular Occlusion SystemKRD · Traditional | Okami Medical, Inc. | 04/10/2026SE |
| K253511 | Concerto Versa Detachable CoilKRD · Traditional | Medtronic, Inc. | 01/14/2026SE |
| K253677 | Tembo Embolic SystemKRD · Special | Instylla, Inc. | 12/15/2025SE |
| K253376 | OBSIDIO Conformable Embolic (M0013972101010)KRD · Special | Boston Scientific Corporation | 10/30/2025SE |
| K250209 | Polyvinyl Alcohol Embolic MicrospheresKRD · Traditional | Canyon Medical, Inc. | 09/23/2025SE |
| K250133 | HARBOR Occlusion DeviceKRD · Traditional | Nuvascular, Inc. | 07/09/2025SE |
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| K944966 | Unipolar Atrial Temporary Pacing Lead,Model 6492LDF · Traditional | 07/14/1995SE |
| K944957 | Temporary Myocardial Pacing Lead, Model 6500LDF · Traditional | 07/14/1995SE |
| K893207 | Closed Chest Support CircuitDTZ · Traditional | 12/12/1989SE |
| K893678 | Duran Flexible Annuloplasty Ring & Obturator H601HKRH · Traditional | 11/27/1989SE |
| K891687 | Extracorporeal Circuit with Bio-Active SurfaceDTZ · Traditional | 05/31/1989SE |
| K891230 | Maxima* Hollow Fiber Oxygenator W/Filtered Reserv.DTZ · Traditional | 05/19/1989SE |
| K885154 | Intersept* Crystalloid Cardioplegia Deliv. SystemKRJ · Traditional | 02/22/1989SE |
| K884390 | Intersept* Crystalloid Cardioplegia FilterKRJ · Traditional | 12/21/1988SE |
| K884244 | Intersept* Prebypass FilterKRJ · Traditional | 12/05/1988SE |
| K883439 | Intersept*Crystalloid Cardioplegia Delivery SystemDTR · Traditional | 10/13/1988SE |
Questions and answers
When was Intersept* Oxygen Gas Line Filter cleared by the FDA?
Intersept* Oxygen Gas Line Filter (K882136) received a 510(k) decision of Substantially Equivalent on August 11, 1988, 83 days after the submission was received.
What is the product code of K882136?
The FDA product code is KRD – Device, Vascular, For Promoting Embolization, a Class II (moderate risk) device regulated under 21 CFR 870.3300.