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FDA 510(k)

BAIM TM CORONARY SINUS FLOW THERMAL

K-Number: K810360 · 1981-03-11

ApplicantElectro-Catheter Corp.
Decision Date1981-03-11
Product CodeDQO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BAIM TM CORONARY SINUS FLOW THERMAL is the device name listed in this FDA 510(k) record. The listed applicant is Electro-Catheter Corp.. It received FDA 510(k) clearance on 1981-03-11 under 510(k) number K810360. The device is classified under product code DQO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BAIM TM CORONARY SINUS FLOW THERMAL?

BAIM TM CORONARY SINUS FLOW THERMAL is a medical device that received FDA 510(k) clearance on 1981-03-11. The listed applicant is Electro-Catheter Corp.. The 510(k) number is K810360.

When did BAIM TM CORONARY SINUS FLOW THERMAL receive FDA 510(k) clearance?

BAIM TM CORONARY SINUS FLOW THERMAL received FDA 510(k) clearance on 1981-03-11, under 510(k) number K810360.

Who is the listed applicant for BAIM TM CORONARY SINUS FLOW THERMAL?

The FDA 510(k) record lists Electro-Catheter Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BAIM TM CORONARY SINUS FLOW THERMAL?

The FDA product code for BAIM TM CORONARY SINUS FLOW THERMAL is DQO.

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Other records listing Electro-Catheter Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K934785MULTIPACEK933451OPEN TIP MULTI-ELECTRODE CATHETER, MODIFICATIONK933450CLOSED TIP MULTI-ELECTRODE CATHETER, MODIFICATIONK943257TIP DEFLECTOR (GENESIS)K934787SILICORE SEMI-FLOATERK874154ELECATH(R) TRANSESOPHAGEAL PACING CATHETER

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Related Devices (Code: DQO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261455Arterial Pressure Monitoring Set/TraySpectrum VascularK252702Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGF, TD2502NDGF, TD2502NDCF, TD2502NDCGF, TD2502NXCF, TD2502NDXF, TD2502NXCGF, TD2502NDXGF, TD2502NDXCF, TD2502NDXCGF, TD2502-110NF, TD2502-110NGF, TD2502-110NDF, TD2502-110NCF, TD2502-110NDGF, TD2502-110NDCF, TD2502-110NCGF, TD2502-110NDCGF, TD2502-110NXF, TD2502-110NXGF, TD2502-110NDXF, TD2502-110NXCF, TD2502-110NDXGF, TD2502-110NDXCF ,TD2502-110NXCGF, TD2502-110NDXCGF, TD2602NF, TD2602NBioptimal International Pte. , Ltd.K254278Arterial Pressure Monitoring Set/TraySpectrum VascularK250751DualView CatheterTerumo CorporationK242966Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging CatheterGentuity, LLCK242420pNOVUS 21 MicrocatheterPhenox, Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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