IS-1/QUADRIPOLAR Terminal Cap, Part Number 6011069
FDA 510(k) K950140 · Pacesetter, Inc.
510(k) numberK950140
Submission
- Device name
- IS-1/QUADRIPOLAR Terminal Cap, Part Number 6011069
- Applicant
- Pacesetter, Inc.
Sylmar, CA, US - Received
- January 13, 1995
- Decision date
- April 6, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DTD – Pacemaker Lead Adaptor
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.3620
- Specialty
- Cardiovascular
- Implant
- Yes
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| K952206 | Passive Plus Pacing Leads with Titanium Nitride CoatingDTB · Traditional | 08/31/1995SESP |
| K951950 | Passive Plus Pacing Leads with Titanium Nitride CoatingDTB · Traditional | 08/31/1995SESP |
| K951087 | Tendril, Unipolar Endocardial Screw-In LeadDTB · Traditional | 06/29/1995ST |
Questions and answers
When was IS-1/QUADRIPOLAR Terminal Cap, Part Number 6011069 cleared by the FDA?
IS-1/QUADRIPOLAR Terminal Cap, Part Number 6011069 (K950140) received a 510(k) decision of Substantially Equivalent on April 6, 1995, 83 days after the submission was received.
What is the product code of K950140?
The FDA product code is DTD – Pacemaker Lead Adaptor, a Class II (moderate risk) device regulated under 21 CFR 870.3620.