Pace Medical
Waltham, MA, US
Pace Medical appears in FDA device records in Waltham, MA. FDA records list 19 510(k) clearances between and , 9 PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 19
- PMA records
- 9
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 19 510(k) clearances for Pace Medical between 1987 and 2001. The busiest year on record is 2000, with 4. The most recent is 2001, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1987 | 3 |
| 1988 | 1 |
| 1989 | 1 |
| 1990 | 2 |
| 1991 | 3 |
| 1992 | 1 |
| 1993 | 1 |
| 1994 | 1 |
| 2000 | 4 |
| 2001 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K011980 | ADAPTER, PACING ANALYZER/UNIVERSAL PACING ADAPTER, MODELS 4820 AND 4825 | DTE | Substantially Equivalent | |
| K012392 | DISPOSABLE SURGICAL EXTENSION CABLE, MODEL 4255 AND MODEL 4260 | DSA | Substantially Equivalent | |
| K002204 | PACEMAKER EXTENSION CABLE MODELS 4265,4265A, 4265V, 5265, 5265A, 5265V | DTE | Substantially Equivalent | |
| K002497 | MODEL 4810 ANALYZER OUTPUT ADAPTER | DTC | Substantially Equivalent | |
| K002496 | MODEL 4815 ADAPTER | DTN | Substantially Equivalent | |
| K001180 | TEMPORARY PACEMAKER EXTENSION CABLE, MODELS 5235, 5235A, 5235V, TEMPORARY PACEMAKER SURGICAL EXTENSION CABLE, MODELS 528 | DTE | Substantially Equivalent | |
| K925143 | MODEL 4800 ACCUPACE PACING SYSTEM ANALYER | DTE | Substantially Equivalent | |
| K931662 | LEAD INTRODUCER SET, VARIOUS MODELS AND SIZES | DYB | Substantially Equivalent | |
| K922899 | MODEL 4280 SURGICAL EXTENSION CABLE | DSA | Substantially Equivalent | |
| K913805 | MINIATURE MODELS 4562/4563/4572/4573 PACEMAKER | DTE | Substantially Equivalent | |
| K913134 | MODEL 4220 | DXY | Substantially Equivalent | |
| K912545 | MODEL 4205 PULSE GENERATOR SURGICAL EXTEN CABLE | DXY | Substantially Equivalent | |
| K902679 | MODELS 4201, 4231 & 4235 EXTENSION CABLES | DTE | Substantially Equivalent | |
| K896352 | MODEL EC4542G MINIATURE | DTE | Substantially Equivalent | |
| K890988 | MODEL 3110 HEART WIRE & 3110P PEDIATRIC HEART WIRE | LDF | Substantially Equivalent | |
| K874743 | PACING LEADS MODEL 3262VU/VB, 3362VU/VB, 3380/3390 | DTB | Substantially Equivalent | |
| K871915 | MINIATURE TEMP. CARDIAC PACEMAKERS EC4542 & EC4543 | DTE | Substantially Equivalent | |
| K870323 | MODEL EV4543 MINIATURE TEMPORARY CARDIAC PACEMAKER | DTE | Substantially Equivalent | |
| K864153 | PACE IMPLANT. LEAD/TINED/ATRIAL/J/MODEL 3290 | DTB | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- DTCAnalyzer, Pacemaker Generator Function
- DSACable, Transducer And Electrode, Patient, (Including Connector)
- LDFElectrode, Pacemaker, Temporary
- JOQGenerator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)
- DXYImplantable Pacemaker Pulse-Generator
- DYBIntroducer, Catheter
- DTBPermanent Pacemaker Electrode
- DTEPulse-Generator, Pacemaker, External
- DTNReservoir, Blood, Cardiopulmonary Bypass
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain