ABIOMED PERIOTEMP(TM) PROBE
FDA 510(k) clearance K885075 · decided 1989-02-13
Clearance details
- K-number
- K885075
- Device name
- ABIOMED PERIOTEMP(TM) PROBE
- Applicant
- Abiomed, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-12-08
- Decision date
- 1989-02-13
- Days to decision
- 67 days
- Clearance type
- Traditional
- Product code
- EIL
- Device class
- 1
- Regulation number
- 872.4565
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Danvers, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ABIODENT PERIOTEMP(R) SYSTEM (K911643) | Abiomed, Inc. | 1991-07-09 |
| FLORIDA PROBE PERIODONTAL PROBE (K890493) | Florida Probe Corp. | 1989-03-13 |
| MODEL 200A ELECTRONIC FORCE-SENSING PROBE (K884813) | Vine Valley Research | 1989-01-05 |
| PERIODONTAL PROBE - AUTOPROBE (K880209) | Dentsply Intl. | 1988-04-27 |
| CREMEEN ALVEOLAR BONE CALIPER (K872098) | Bowen & Company, Inc. | 1987-07-31 |
| PERIO-TEST (K872215) | Dr. Bernard Loewenthal | 1987-07-10 |
| PIO ROOT CANAL INDICATOR (K822793) | National Patent Development Corp. | 1982-10-22 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Impella CP with SmartAssist; Impella 5.5 with SmartAssist (P140003/S136) | Abiomed, Inc. | 2025-12-19 |
| Impella CP with SmartAssist; Impella 5.5 with SmartAssist (P170011/S062) | Abiomed, Inc. | 2025-12-19 |
| Impella 5.5 with SmartAssist (P140003/S131) | Abiomed, Inc. | 2025-10-01 |
| Impella CP with SmartAssist (P140003/S130) | Abiomed, Inc. | 2025-09-24 |
| Impella 2.5; Impella CP; Impella CP with SmartAssist; Impella 5.0; Impella 5.5 with SmartAssist; Impella LD (P140003/S129) | Abiomed, Inc. | 2025-09-19 |
| Impella RP, Impella RP with SmartAssist, Impella RP Flex with SmartAssist (P170011/S060) | Abiomed, Inc. | 2025-09-19 |
| Purge Cassette (P170011/S058) | Abiomed, Inc. | 2025-09-15 |
| Impella 5.5 with SmartAssist, Impella CP with SmartAssist, Purge Cassette (P140003/S126) | Abiomed, Inc. | 2025-09-15 |