FDA product code DSS: Clip, Vascular
DSS is the FDA product code for clip, vascular. It is a Class II device, regulated under 21 CFR 870.3250 and reviewed by the Cardiovascular panel. FDA has cleared 8 510(k) submissions under DSS, from 8 different applicants. The average 510(k) review took 94 days (median 91). FDA has posted 4 recalls for DSS devices.
Classification
| Field | Value |
|---|---|
| Device name | Clip, Vascular |
| Device class | Class II |
| Regulation | 21 CFR 870.3250 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Implant | Yes |
Compare with all 510(k) review times · Search every DSS clearance
Top DSS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Applied Medical Resources | 1 | 1999-01-21 |
| Heartport, Inc. | 1 | 1996-11-15 |
| Puritas Health Care, Inc. | 1 | 1992-04-20 |
| Research Medical, Inc. | 1 | 1992-04-15 |
| Catheter Research C/O Burditt, Bowles & Radzius | 1 | 1992-01-10 |
3 more applicants have DSS clearances. See the full list in Caduvo.
Most recent DSS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K983744 | Applied Medical Resources | MCAS (MODULAR CLIP APPLIER SYSTEM) | 1999-01-21 | 90 |
| K961333 | Heartport, Inc. | HEARTPORT MULTIFIRE CLIP APPLIER | 1996-11-15 | 221 |
| K920104 | Puritas Health Care, Inc. | IDENTI LOOPS DEGANIA SILICONE | 1992-04-20 | 102 |
| K920676 | Research Medical, Inc. | RMI SOFCLAMP | 1992-04-15 | 61 |
| K914523 | Catheter Research C/O Burditt, Bowles & Radzius | CRI VESSEL OCCLUSIN SYSTEM/CRI OCCLUSION COIL | 1992-01-10 | 92 |
Recalls for DSS devices
4 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2020-01-31.
| Year | Recalls |
|---|---|
| 2020 | 4 |
Frequently asked questions
What is FDA product code DSS?
DSS is the FDA product code for clip, vascular. It is a Class II device, regulated under 21 CFR 870.3250 and reviewed by the Cardiovascular panel.
What device class is DSS?
Class II, regulation 21 CFR 870.3250. Typical premarket route: 510(k).
How long does a 510(k) take for product code DSS?
Across 8 cleared submissions the average was 94 days from receipt to decision (median 91).
Which companies have the most DSS clearances?
Applied Medical Resources (1); Heartport, Inc. (1); Puritas Health Care, Inc. (1); Research Medical, Inc. (1); Catheter Research C/O Burditt, Bowles & Radzius (1).
Have DSS devices been recalled?
Yes: 4 product recalls across 1 recall events; the most recent began 2020-01-31.
Next steps
- Run an FDA pathway report with predicate devices for product code DSS
- Run a recall and safety report across every DSS manufacturer
- Watch product code DSS for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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