FDA 510(k) K874154, ELECATH(R) TRANSESOPHAGEAL PACING CATHETER, by Electro-Catheter Corp.
FDA 510(k) K874154, ELECATH(R) TRANSESOPHAGEAL PACING CATHETER, by Electro-Catheter Corp.
FDA 510(k) records for ELECATH(R) TRANSESOPHAGEAL PACING CATHETER (K874154), submitted by Electro-Catheter Corp..
- 510(k) Number: K874154
- Device Classification: Tubes, Gastrointestinal (And Accessories)
- Applicant: Electro-Catheter Corp.
- Date Received: 10/13/1987
- Decision Date: 04/29/1988
- Decision: Substantially Equivalent (SESE)
- Regulation Number: 876.598
- Product Code: KNT
- Regulation Medical Specialty: Gastroenterology/Urology
- Review Panel: Gastroenterology/Urology
- Total Pages: 223 (80 unredacted, 64% redacted overall)
What's in this document (sections may appear in any order):
- ✗ 510(k) Summary / Statement: 100% redacted
- — Indications for Use: no distinct section found
- ✓ Device Description: 0% redacted
- ✗ Substantial Equivalence / Predicate: 66% redacted
- — Performance / Bench Testing: no distinct section found
- — Biocompatibility: no distinct section found
- — Software / Cybersecurity: no distinct section found
- ✗ Sterilization / Shelf Life: 100% redacted
- ✗ Labeling / IFU: 71% redacted
- — Clinical Data: no distinct section found
- — FDA Correspondence: no distinct section found
- — Risk Analysis / FMEA: no distinct section found
- — Electromagnetic Compatibility (EMC): no distinct section found
Section contents and redaction percentages are AI-assisted estimates based on automated document analysis. Actual content may vary.
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